Having the right medical device regulatory consulting partner at the right time can be invaluable in attaining compliance and market access. NAMSA is the industry leader in driving successful medical device and IVD regulatory submissions and outcomes through effective, daily interactions with the U.S. FDA, Japan’s PMDA, Europe’s Notified Bodies, China’s NMPA and other international authorities. In fact, many of our Associates have previously held positions within these organizations, which provides clients the benefit of a clear understanding on how to proactively plan for international requirements and expectations.
We provide a wide range of medical device and IVD regulatory consulting services across the full spectrum of product design and development through post-market support. From Notified Body selection and Pre-IDE preparation to Advisory Panel Meetings, our medical device regulatory consultants develop and implement global regulatory strategies to accelerate your specific commercialization efforts—ultimately getting you to market faster so you may make a more immediate impact on patient safety and healthcare.
With our medical device quality consulting approach, you maintain project control while gaining the benefit of on-demand external support—whether the goal is to extend your in-house capabilities or obtain access to the specialized expertise you need.
Biological Safety & Validation Consulting
A wide range of medical devices are introduced almost daily in today’s global marketplace, which is often marked with the challenge of adhering to the industry’s constantly changing international standards and guidelines. Planning for biological safety is as much a business necessity as it is a regulatory requirement.
Any novel device must undergo assessment for biological hazards, risk characterization and toxicological risk assessment while also meeting the test requirements of varying international marketplaces and geographies. As a trusted medical device regulatory solutions company, NAMSA can help you identify and mitigate these risks.
At NAMSA, we offer a range of biological safety solutions to ensure your medical device development program is compliant, while also focusing on the most efficient means possible to complete necessary tests.
Biological Evaluation Plan
This is the first step of the biological evaluation for medical devices. This step is most often utilized for new devices not previously marketed, and may be needed for existing devices undergoing modifications. The Biological Evaluation Plan summarizes and characterizes a medical device based on the nature and duration of body contact, assesses the selection and materials of construction, reviews the manufacturing processes, identifies the biological endpoints of concern, evaluates any existing research data available and recommends and supports a strategy (plan) to address areas of remaining biological risk, which may include both chemical and biological testing.
Biological Evaluation Report
As part of a Biological Evaluation Report, NAMSA’s biological safety experts perform an overall evaluation of a device/family of devices with specific consideration to the type of patient contact and intended clinical use, potential hazards associated with the materials of construction, the history of clinical use of the materials of construction, manufacturing process information, the results of biocompatibility and chemical characterization testing performed on the device, the clinical history of the device, and other information available within the literature. The biological evaluation report is prepared according to the current requirements for the biological evaluation of medical devices (i.e. ISO 10993-1, FDA Biocompatibility Guidance, ISO 14971) using a risk management-inspired structure as outlined below.
- Risk analysis, including a review of raw materials data (at a minimum), manufacturing process/es and when available, non-clinical studies, clinical data and post-market surveillance data
- Risk evaluation (i.e., discussion based on gathered information to determine whether or not risk control measures [complementary tests] are necessary)
- Risk control (i.e., testing plan, including chemical characterization and/or biological tests to mitigate identified/remaining biological risks not appropriately addressed)
- Overall risk assessment (i.e., after implementation of risk control measures, when required, to determine whether implemented measures are sufficient to mitigate risks or whether any new risks are raised and further investigations are necessary)
- Re-assessment of risk (in the case of device changes)
Toxicological Risk Assessment
This assessment evaluates the toxicity of individual chemical ingredients of the formulation used to manufacture a particular medical device. The assessment typically includes tests for chemical composition, extractables and/or leachables, and evaluation of any degradable or leachable materials to determine patient biological risk. This assessment is often a component of a Biological Evaluation Report where analytical chemistry testing is performed.
NAMSA’s Equivalency Assessment evaluates the equivalency of a device to another similar marketed product. A typical request includes equivalency regarding data and properties for clinical, technical and biological parameters, methods of use, materials as well as equivalent clinical, technical and biological properties performance.
NAMSA’s team of Board Certified Toxicologists (DABTs) are available to provide credibility as a third-party reviewer and to vigorously critique scientific claims and research to ensure integrity of data and resultant claims.
Adverse Test Result Technical Memo
NAMSA’s technical experts can assist in delivering technical clarity of adverse results, associated implications and relevance to the known biological/toxicological endpoints relative to a specific medical device and regulatory pathway(s).
NAMSA offers comprehensive analyses detailing acceptable and deficient areas (Gap) between an existing set of data and new regulatory requirements for devices, including reports of remediation and sequence recommendations.
NAMSA provides industry-leading biological safety training to the medical device industry. With over 2,000 attendees to date, our customized approach to applying ISO 10993 principles and other regulatory guidance in everyday scenarios is unrivaled within the medical device marketplace. NAMSA provides three specialty courses focused on the biological evaluation of medical devices including: biological safety specialist certification, advanced workshops on the biological evaluation process and custom workshops focused on chemical characterization.
CE Mark Consulting
Whether launching a new medical device in Europe or transitioning a legacy device previously certified under MDD to MDR, NAMSA’s global team of medical device regulatory consultants, made up of former Notified Body staff and experts, can help you successfully achieve your unique development objectives and goals.
NAMSA, the CRO industry leader in medical device regulatory and quality consulting services, proudly offers the following CE Mark solutions to EU Clients:
- Assistance for drug/device combination device manufacturers under Rule 14
- Assistance for manufacturers of In Vivo origin products (EU Regulation 722/2012 & EN ISO 22442)
- Conformity Assessment procedures under MDR 2017/745
- Device classification and regulatory pathway consulting
- ISO 14971 risk management support
- MDR technical documentation gap analyses
- Notified Body observations and non-conformity responses
- Notified Body selection
- Reprocessing of disposable products under MDR
- Technical Documentation compilation
- UKCA Marking
- Unique Device Identifier (UDI)
Assistance for Manufacturers of Drug/Device Combination Devices under Rule 14
In the European Union (EU), products combining a medical device and a medicinal component are regulated as either a medical device or a pharmaceutical, dependent on the primary mode of action. If a device demonstrates the primary mode of action is physical and the medicinal component has an ancillary impact, the product will be regulated as a medical device under Rule 14 of the MDR.
However, there is a significant regulatory burden associated with drug/device combination products within the EU in that it is necessary to compile and submit a medicinal component consultation dossier to a Competent Authority. This dossier must be approved before a design examination certificate can be issued by any Notified Body (NB), as it forms part of a device company’s submission to its NB (whom liaises with the chosen Competent Authority on behalf of the manufacturer).
In addition, the timeframe for the review of a medicinal consultation dossier can be lengthy and expensive. These timeframes are dependent on whether the medicinal component is a known substance to the Competent Authority and from a known source.
NAMSA medical regulatory consultants have significant experience of compiling and reviewing technical documentation and medicinal substance dossiers (the Common Technical Document [CTD format]) for drug/device products. This experience ranges from wound dressings to heart valves and drug coated stents.
Assistance for Manufacturers of In Vivo Origin Products (EU Regulation 722/2012 & EN ISO 22442)
Device manufacturers that utilize tissues of In Vivo origin face additional regulatory burdens as they must demonstrate how a device has mitigated the inclusion of In Vivo tissues by complying with EN ISO 22442 (Parts 1-3) and Commission Regulation 722/2012. While the EU Commission regulation is applicable only to tissues originating from Transmissible Spongiform Encephalopathies (TSE) susceptible species, the ISO standard is applicable to all medical devices that utilize In Vivo tissues during the manufacturing process.
These medical devices are considered to be Class III products regulated under Rule 18. This rule captures products that utilize In Vivo tissue only in the manufacturing process, but are not present in the final device.
To assist with In Vivo origin products, NAMSA has medical device regulatory consultants with significant experience in devices that utilize these tissue types. Many of these experts have previously served as Notified Body reviewers of high-risk medical devices and/or have been involved in the CE marking of over 100 medical devices that utilize In Vivo materials.
Device Classification and Regulatory Pathway Consulting
An important first step in any medical device registration project is to ensure that a device is correctly classified. A device should clearly indicate whether it will be regulated as a device under MDR 2017/745 or IVDR 2017/746, with another key consideration for rules that fall under each regulation. This can be a complicated task for manufacturers, for example, there are now 22 different classification rules under the MDR as compared to 18 rules under MDD. These considerations are key as rules may influence the amount of supporting data required, or even impact the choice of a Notified Body (NB).
In complex cases, it may be necessary to confer with either an NB or a Competent Authority regarding the classification of a particular technology.
Once a device classification is determined, a manufacturer can further develop the appropriate regulatory pathway by considering questions such as:
- What is my product design and development strategy?
- How will I meet General Safety and Performance Requirements (GSPRs)?
- What preclinical testing will be required (bench, In Vitro and In Vivo)?
- What would the cleaning, disinfection, sterilization, packaging validation of my device look like?
- What biocompatibility data will I need to provide to meet ISO 10993 requirements?
- Will we need to conduct a clinical investigation prior to CE marking?
- If so, will this include multiple studies (first in man, feasibility and pilot studies, pivotal studies, etc.)?
- How large will these investigations need to be?
- Can we use data collected in another market?
- What Post-Market Clinical Follow-Up (PMCF) activities must I implement?
- Which Notified Body has the most experience with our specific technology?
As medical device regulatory consultants, NAMSA has significant experience in assisting device manufacturers with classification and setting the most appropriate regulatory pathway forward for success. Guiding manufacturers every step of the way, we ensure that project goals are met, in part by relying on our team’s former Notified Body work experience and management of hundreds of CE Mark projects in recent years.
While the journey to securing a CE Mark can be somewhat tedious under MDR, an additional critical component to consider as early as possible within development is the ability for a specific device to achieve market access and reimbursement.
Health technology assessments and reimbursement rules differ within EU states, making it critically important to integrate the necessary market access activities upfront. These steps can also save manufacturers time and money on the road to not only reimbursement, but device commercialization.
While device manufacturers know to focus and generate evidence to demonstrate that devices are safe and effective to support regulatory submissions, often missed is the key question as to whether a device or technology is reasonable and necessary and worthy of coverage/reimbursement. On the road to coverage, data must be maximized within the device approval submission to also support health economics and reimbursement requirements and demonstration of need. During this process, it is also important to consider whether EU member states have different expectations in clinical data to support reimbursement and the overall clinical plan.
To assist manufacturers with these very important needs, NAMSA has a full team of Reimbursement Strategists—serving as part of our Regulatory and Clinical Teams—to help determine synergies and setting strategies to avoid common pitfalls. This allows device makers to maximize market access for new and legacy devices and set a strategy for long-term success.
ISO 14971 Risk Management Support
As part of a medical device manufacturer’s technical documentation and quality management system, risk management processes that comply with ISO 14971 must be included. The risk management file is a key part of a manufacturer’s documentation that links to technical documentation, quality systems, clinical evaluation and even a device’s instruction for use.
NAMSA has a robust team of consultants with experience pertaining to risk management planning, conducting risk analyses, developing risk management tools and integrating outputs of a risk management report into an organization’s Post-Market Surveillance (PMS) procedures.
MDR Technical Documentation Gap Analysis
All new devices and significantly modified legacy devices within the EU must be CE marked under the Medical Device Regulation (MDR). However, there is still a large number of manufacturers who hold valid CE Marks under the MDD for legacy devices that must transition to MDR by May 2024; for practical purposes, manufacturers should submit application to their NB by 2023, at the latest.
In addition, the MDR introduces a number of significant changes and focuses more attention on a lifecycle approach to medical device regulation. It also expands the scope of what is considered a medical device, introduces more strict clinical data requirements and additional post-market oversight and responsibility.
NAMSA has assisted hundreds of medical device manufacturers with conducting comprehensive and systematic gap analyses of existing technical documentation, inclusive of highlighting deficiencies requiring attention to comply with MDR requirements. When working with NAMSA, Clients also have the benefit of collaborating with former Notified Body personnel who possess significant expertise and MDR experience.
Notified Body Selection
Prior to placing a medical device on the EU market, device manufacturers must first obtain CE marking certification via the Medical Device Regulation (MDR). For the majority of devices within the EU, this certification is obtained via a regulatory agency termed a Notified Body (NB).
Choosing the best-fit NB is more critically important than ever provided the current regulatory landscape within the region.
Important questions for EU manufacturers to consider prior to selecting a NB are as follows:
- Do they possess the correct designation and scope to undertake a CE marking assessment of your specific technology?
- Do they have personnel with experience of technology similar to yours?
- Does the NB have the bandwidth to collaborate in a timely manner and to meet required deadlines?
- Are they able to certify quality management systems?
- Do they provide services applicable to other regions?
Taking into account a manufacturer’s technology, desired timeframes and future market access plans, NAMSA’s Team of EU regulatory experts are here to help you select the right Notified Body to achieve your unique business goals and long-term success.
Technical Documentation Compilation
All medical devices and IVD products in the EU require technical documentation and in the majority of cases, these files must be reviewed by a Notified Body prior to the award of CE Mark.
Whether you need assistance with document compilation for a regulatory submission or a gap analysis review prior to submitting to your Notified Body, NAMSA is here to help!
Some our industry-leading technical documentation consultancy services, include:
- Identification of applicable standards and required testing
- GSPR requirements compilation and/or review
- Labelling and marketing materials review to ensure they are consistent with the claims made for the device
- Compilation of the risk management report in accordance with ISO 14971:2019
- Preparation of clinical evaluation in accordance with the MDR and MEDDEV 2.7.1 (Rev 4), and applicable MDCG guidance
- Development of post market surveillance documentation (PSUR, PMCF Plans and Reports)
- Development of SSCP (Summary of Safety and Clinical Performance)
- Strategic advice and assistance with responding to Notified Body questions
Many of the requirements for CE Marks are to be included in the new UK Conformity Assessed (UKCA) marking scheme that will replace CE Marks under the current MDD, AIMD and IVDD regulatory framework. This framework will remain in place in the UK, with allowance for manufacturers to leverage the CE Mark until June 30, 2023. Following June 2023, all devices placed on the UK market must carry the UKCA Mark.
To assist with these requirements, NAMSA has a team of UK-based medical device regulatory consulting experts to support manufacturers through these new processes, as well as advising on the continued evolution of the UK medical device regulatory framework.
Chinese MedTech Development
Medical devices and In Vitro Diagnostics (IVDs) in China are regulated by the National Medical Products Association (NMPA). All manufacturers of devices and diagnostics must register their products with the NMPA and obtain a Medical Device Registration Certificate (MDRC) before products can legally be placed within the Chinese marketplace.
As in most other major markets of the world, devices in this APAC region are regulated by risk classification: Class I, Class II and Class III. However, it is important to note that the risk classification of a particular device may not correspond directly to an EU or U.S. class, but one commonality is that regulatory oversight increases with each progressive classification level.
Additionally, Class II and III devices, in most cases, require local testing, unless a device meets the NMPA definition of a ‘predicate device,’ already on the market in China. In this instance, a local or overseas clinical study may be required, both of which must meet Chinese Good Clinical Practices (GCP).
With offices in Beijing and Shanghai, and a consulting team of more than 20 Associates, NAMSA can help guide you through the nuances of the Chinese medical device marketplace. Click here to learn more about the following services:
- Chinese Regulatory Strategy
- NMPA Technical File Compilation and Submission
- Medical Writing
- Clinical Study Management
- Quality Systems
- Pre- and Post-Market Support
NAMSA’s U.S. Consulting Team is comprised of several former U.S. Food and Drug Administration (FDA) staff and industry experts, involved in over 500 U.S. FDA Pre-Submission applications in recent years. Leveraging our team’s experience and strong working relationships with U.S. regulators, Clients consistently place trust in NAMSA to accelerate clearance and approvals of innovative technologies.
Whether working on a stand-alone FDA regulatory submission or in a partnership with our inter-disciplinary teams of Preclinical, Clinical, Biostatistics and Reimbursement Strategists, NAMSA possesses a proven track record of successfully leading Clients through all stages of the product development process to mitigate regulatory risks and achieve commercial objectives.
NAMSA is proud to offer the following U.S. FDA Regulatory Consulting Services to Clients around the globe:
- 510(k) Submissions
- Breakthrough Device Program Submissions
- De Novo Submissions
- FDA Regulatory Strategy
- IDE Clinical Study Submissions and Reports
- Premarket Approval (PMA) Submissions
- Safer Technologies Program (STeP) Submissions
- U.S. FDA 483 Mitigation Projects and Strategies
The majority of FDA Class II devices require a cleared 510(k) application submission prior to placement on the U.S. market. NAMSA’s FDA Consulting Team, which includes former FDA personnel, has experience in successfully submitting hundreds of 510(k) applications.
Our teams, specializing in medical devices and IVD products, assist Clients in navigating the 510(k) process and helping bring products to market in an accelerated manner. We work with you to reduce risk and circumvent common pitfalls throughout the regulatory submission process, including avoidance of Refuse to Accept (RTA) notifications and lengthy requests for Additional information (AI) upon FDA submission reviews.
At the outset of a 510(k) project, NAMSA’s experts work with you to identify the most appropriate predicate device(s), in addition to conducting an initial gap analysis of available information. This helps set the stage for what additional reports, testing and data will be required to provide you the best chance of a successful submission. As part of this process, our teams can also compile and submit a 510(k) submission on your behalf and help respond to any follow-up questions stemming from the FDA.
Breakthrough Device Program Submissions
The FDA’s Breakthrough Therapy Designation Program is a means to fast-track devices or device combination products. Commonly, if a device is accepted by the FDA as a breakthrough device, it can benefit from an expedited regulatory pathway via the Breakthrough Program.
Conditions that must be met to achieve breakthrough designation include demonstrating that a device provides more effective treatment/diagnosis of life-threatening or irreversibly debilitating human diseases/conditions and meet at least one of the following criteria:
- Represent breakthrough technology
- No approved or cleared device/therapy alternative exists
- Offers significant advantages over existing approved or cleared alternatives
- Device availability is in the best interests of patients
NAMSA can assist Clients in making the determination as to whether or not their technology is likely to meet these requirements. We can also compile the presentation of a particular technology to the FDA, typically via a pre-submission (Q-submission) meeting.
De Novo Submissions
The U.S. FDA De Novo process is a means by which novel technologies that do not have an appropriate predicate device or product code, but for which general or special controls could provide reasonable assurance of safety and effectiveness, can ultimately be assessed by the FDA for premarket clearance.
There are two conditions under which a manufacturer can consider a De Novo request:
- Following a Not Substantially Equivalent (NSE) determination by the FDA to the submitter’s 510(k) submission
- At the outset of the regulatory project if a manufacturer has determined that there is no legally marketed predicate device to base a 510(k).
NAMSA recommends that manufacturers engage with the FDA via a Pre-Submission meeting to discuss the applicability of a De Novo submission under these circumstances. If the FDA supports a De Novo submission, the manufacturer will submit a De Novo request submission without reference to a predicate device. If it is accepted, then the manufacturer will be cleared to market the product in the U.S. and future applicants will have the ability to use the manufacturer’s product as a predicate device in their 510(k)s.
FDA Regulatory Consulting Strategy
The FDA regulates medical devices based on potential risks posed to patients. However, determining the classification and optimal roadmap to product clearance/approval is not always straightforward.
Key considerations for device makers, include:
- What is the correct product code and regulation number under which a device will be regulated?
- What consensus standards are applicable?
- What testing will I need to conduct?
- What clinical data should I need to provide with my submission?
- What is the most appropriate predicate device on which to base my submission?
- How will my regulatory strategy impact reimbursement of my technology?
- Do I need to consider a Q-Submission before submitting our regulatory filing?
NAMSA’s team of FDA consultants can help you answer all of these questions and more by developing a robust submission strategy that will also outline the likely timeframe and cost of bringing your technology to the U.S. market.
IDE Clinical Study Submissions and Reports
If a device maker is developing a new product/indication for an existing device prior to market approval and has determined a clinical investigation is required, the first consideration is whether the proposed investigation is considered a ‘significant’ or ‘non-significant’ risk to the patients. If determined that a clinical investigation will not pose a significant risk, then only an Institutional Review Board (IRB) approval is required before an investigation can commence. If, however, a device presents significant risk, both IRB and an FDA Investigational Device Exemption (IDE) is required.
Typically, IDEs are required for devices that must undergo a Premarket Approval (PMA) process—although 510(k) submissions still require some clinical data upon submission.
NAMSA can support companies wishing to submit for an IDE with the following processes:
- Helping with the determination of significant vs. non-significant risk
- Assisting with the pre-submission meeting to discuss risk determination, clinical study outline, and other components
- Compilation of IDE documents
- Facilitation and management of required clinical studies
- PMA Submissions
Premarket Approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and performance of Class III (high-risk) medical devices. Given the risk associated with Class III devices, the device PMA process is more stringent, expensive and usually takes much longer than a Class II 510(k) submission.
A PMA submission can be a traditional PMA in which all requisite information is submitted in its entirety. However, another method is to submit a modular PMA where sections such as preclinical, manufacturing and clinical can be submitted separately to the FDA. This method is particularly appropriate if a company is collecting clinical data while other sections of the PMA have been developed and submitted.
Another important differentiation with PMA submissions is that a company’s manufacturing facilities and quality system will be audited by the FDA during the submission process and must meet the FDA’s requirements before PMA approval.
Post-approval, manufacturers must submit annual reports to the FDA, with ‘PMA supplements’ required for any significant changes made to a device or its claims.
NAMSA can assist manufacturers with PMA submissions through:
- Assistance with the pre-submission process whereby key issues pertaining to the final submission will be discussed with the FDA
- Support with the compilation of PMA sections
- Management and facilitation of required preclinical testing
- Management of required clinical investigation (worldwide)
- Preparation and representation for advisory panel meeting reviews
- Preparation of PMA supplements and annual PMA reports
When a U.S. manufacturer develops their FDA regulatory strategy, there may be a number of unknowns surrounding required testing, the clinical data to provide and whether the clinical data already collected in a different market is considered sufficient. Rather than compile and submit your regulatory filing without answers to these fundamental questions—and risk a lengthy AI letter—NAMSA recommends that manufacturers consider submitting a Q-Submission to FDA to obtain clarity and to address potential concerns before finalization of a regulatory filing.
Within the Q-Submission process, a manufacturer engages with the FDA at no additional fee to present key questions and receive specific feedback. While this process adds time at the beginning of any development project, in NAMSA’s experience, it undoubtedly provides manufacturers a better chance of achieving successful submission outcomes while shortening overall project timelines—saving valuable resources.
NAMSA’s Team of medical device regulatory consultants puts their expertise to work for you. Involved in over 500 Q-Submission/Pre-Submission meetings for 510(k)s, De Novos and PMAs, and weekly interactions with the agency we take great care to mitigate risk, pose the correct questions to the FDA and focus on acceleration of the approval process for your device.
Safer Technologies Program (STeP) Submissions
For companies developing products aimed at treating diseases/conditions associated with morbidities and mortalities (less serious than those associated with Breakthrough Devices), the FDA has a new and voluntary program—SteP—for these device types which are expected to significantly improve the safety of currently available treatments.
The aim of the program is to allow patients more timely access to devices by expediting the assessment and review of associated regulatory submission processes, be it a 510(k), De Novo, PMA submission. The program is modelled on the previously introduced Breakthrough Devices Program and similarly allows for interactive, complimentary and timely discussions with FDA.
U.S. FDA 483 Mitigation Projects and Strategy
Following any FDA inspection, a manufacturer may be presented with a Form 483, which typically outlines an inspector’s observations and potential violations of the Food Drug and Cosmetic Act and other related acts. As part of the inspection process, an organization may also receive an FDA warning letter for a variety of reasons.
Whether a company has received a Form 483 or warning letter, NAMSA can assist manufacturers in a number of ways:
- Analysis of Form 483 or warning letter
- Develop a remediation plan
- Work directly with Clients on addressing FDA questions
- Act as liaison to Clients in all FDA correspondence
FDA U.S. Agent Services
As part of FDA’s Medical Device Registration and Listing requirements pertaining to medical device approval, organizations outside the United States must designate an FDA U.S. Agent. (Click here to view information from the FDA on U.S. Agent responsibilities.
All foreign establishments must notify the FDA of the name, address and phone number of their U.S. Agent. The U.S. Agent must either reside in the U.S., or maintain a place of business in the U.S., and must be available to answer the phone during normal U.S. business hours.
The responsibilities of a U.S. Agent are as follows:
- Assisting FDA in communications with the foreign establishment;
- Responding to questions concerning the foreign establishment’s products that are sold in the United States;
- Assisting FDA in scheduling inspections of the foreign establishment; and
- If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be equivalent to providing the same information or documents to the foreign establishment.
Should you need additional services, NAMSA can provide regulatory, medical device testing, preclinical, clinical and quality/compliance services to meet FDA requirements for 510(k)s, PMAs and IDEs. These services include, but are not limited to: FDA annual establishment registration and device listing, official correspondent responsibilities, resolution of import issues, regulatory strategy, required biological and/or functional testing, clinical study design and conduct, medical device quality systems development/implementation and writing regulatory submissions.
International Medical Device Registration Consulting
NAMSA is the medical device industry’s leading Contract Research Organization (CRO) that provides clear direction and focus to assist manufacturers seeking to commercialize in varying geographies and markets, including EU Member Nations, Canada, Australia, Switzerland and others.
Some of NAMSA’s most requested registration solutions include:
- Australia Therapeutic Goods Administration (TGA)
- Australia Register of Therapeutic Goods (ARTG)
- Canada Medical Device License (CMDL)
- Canada Medical Devices Registration
- CE Mark Assistance
- Establishing Clinical Trial Regulatory Requirements and Filing Preparation
- EU Technical File Assistance
- Identifying and Recommending Notified Bodies
- ISO 13485 Consulting and Certification
- ISO 14971 Medical Device Risk Management
NAMSA provides a wide range of specialized report writing, manuscript submission and evidence communication services. Our world-class medical writing service team is experts at identifying, organizing, interpreting and presenting clinical data in an accurate and professional manner that is highly recognized and trusted by medical device manufacturers and global regulatory entities. The team is also experienced and skilled in defining and prioritizing which reports are required to comply with the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), MEDDEV 2.7.1 rev. 4, NMPA regulations and a multitude of other regulatory guidelines.
NAMSA’s global team is comprised of more than 30 fully dedicated medical writers from a diverse range of clinical and scientific backgrounds of whom one-third hold doctorates; many have also spent a portion of their careers at leading Notified Bodies. All experts are native or fluent English speakers; other language capabilities include Arabic, French, German, Italian, Japanese, Portuguese, Russian, Spanish and Standard Chinese.
Working in close partnership with NAMSA’s Regulatory, Clinical and Biostatistics Teams, our medical writers are highly responsive to individual needs, and are instrumental in helping clients achieve commercial objectives. When working with NAMSA, clients are also provided a personalized plan to help guide future compliance activities.
Some of our medical writing solutions include:
- Clinical Evaluation Plans (CEPs)
- Clinical Evaluation Reports (CERs)
- Clinical Evidence Summaries (One-Page)
- Clinical Literature Review
- Clinical Study Reports (CSRs)
- Conference Abstracts
- Device Monitoring Reports (DMoR)
- Implant Cards
- Instruction for Use (IFU), User Guide and Labeling (Creation or Editing)
- Investigator Brochures
- Journal Articles: Preclinical and Clinical Study Manuscripts for Submission to Peer-Reviewed Journals
- Labelling, Instructions for Use (IFUs) and User Manuals
- Period Safety Update Reports (PSURs)
- Quality, Security and Usefulness Dossier for Combination Devices
- Scientific Publications and Conference Abstracts
- Summary (and Summaries) of Safety and Clinical Performance (SSCP)
- Systematic Literature Reviews and Associated Meta-Analysis
You may find a full list of NAMSA’s Medical Writing solutions here.
Quality Systems & Compliance
The criticality of the development, implementation, adherence and continuous improvement of a compliant Quality Management System (QMS) cannot be overstated. Not only are these key processes in driving company value, but more importantly, they help ensure patient safety and the delivery of high-quality products to those that need them most.
NAMSA offers comprehensive support to medical device manufacturers in the areas of U.S. FDA Quality System Regulation (QSR), EU Medical Device Regulation (MDR) and ISO standards compliance. Our global medical device Quality Team has supported organizations ranging from Fortune 100 to small start-ups, and many have worked directly for a variety of device Sponsors and global regulatory and compliance entities. This expertise and experience allows our team to uniquely tailor medical device quality systems to the specific needs of each manufacturer, their products and culture.
NAMSA’s global Quality Team can assist you efficient, cost-effective activities such as:
- Audits and Gap Assessments to: FDA 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485 and ISO 9001 Standards, Medical Device Regulation 2017/745 (MDR) and Medical Device Single Audit Program (MDSAP)
- Assistance in resolving gaps identified
- Change Control and Corrective and Preventive Action (CAPA), including Root Cause Analysis
- Design Controls: Review / assess existing procedures and records, develop and implement full design control procedures, processes and records
- Design History File development or Gap Assessment
- Device Master Record (DMR) development or Gap Assessment
- Health Hazard Evaluation (HHE)
- Internal audits
- Pre-BIMO/Mock BIMO inspections
- Process validation
- Quality system development and implementation to: FDA 21 CFR 820 (QSR), ISO 13485, ISO 9001 and Medical Device Regulation (MDR)
- Quality system mock inspections: U.S., EU, China, Japan
- Quality system remediation
- Risk Management Program: Review / assess existing procedures, plans, reports and records; develop and implement plans, risk analyses and reports
- Standards assessments
- Supplier audits