Having the right regulatory partner at the right time can be invaluable in attaining compliance and market access. NAMSA is the industry leader in driving successful 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 regulatory 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 experts 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 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.
Some of our regulatory support programs include:
Audits: Compliance, Mock & Quality
Quality data is the number one driver of company value—and, that’s where NAMSA comes in. We are experienced in helping hundreds of global medical device manufacturers and investors to evaluate company value, minimize risk and proceed with confidence.
Our global experts, many of whom have previously worked for global regulatory entities, partner with clients to assist with:
- Audit or Inspection Remediation Strategy and Support
- Audits to Prepare for Unannounced Visits
- FDA Site and Supplier Audit: Preparation, Training, Support
- Mock Audits and Gap Analysis for Technical Files and Design Dossiers to address Possible Areas of Improvement
- On-Site Training to ensure Quality Compliance
- Quality System Mock Audits (U.S., China, Europe, Japan, Canada)
- Review Design History Files for Compliance with Specific Regulations and Standards
- Review and Assess Risk Management Reports
- Review and Assess Existing Key Procedures, including Post-Production and Monitoring Plans
- Provide Temporary Staff (QSR trained) to assist with CAPAs, Internal Audits, Supplier Audits, Design Controls, Management Reviews and Compliance Management
- Provide Technical Specialists to Audit Subcontractors and/or Suppliers
NAMSA also understands that an essential part of proper regulatory preparation includes the mock audit process. NAMSA is highly experienced with mock audits, which are conducted by our trusted consultants to assist clients with efficient, cost-effective regulatory compliance.
Common mock auditing assignments include:
- Clinical Data Audits
- Clinical Data Suitability for FDA Submission
- Clinical SOPs: Gap Analysis & Development
- Data Management Audits
- FDA Study Site Inspection: Preparation & Support
- Pre-FDA Bioresearch Monitoring (BIMO) Inspection Audits
- Clinical Practices: Evaluation of IRB Documentation, Patient Consent, Investigator Contracts
- Expert Opinion on Statistical Conclusions
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.
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 modificatiosn. 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 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. Wth over 2,000 attendees to date, our customized approach to applying ISO 10993 principles and other regulatory guidance in every day 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.
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, quality systems development/implementation and writing regulatory submissions.
International Medical Device Registration Consulting
NAMSA is the medical device industry’s leading Clinical Research Organization (CRO) that provides clear direction and focus to assist manufacturers seeking to commercialize in a 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 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
NAMSA offers comprehensive support to medical device manufacturers in the areas of U.S. FDA Quality System Regulation (QSR), EU MDR and ISO compliance. Our global consultants have worked with organizations ranging from Fortune 100 to small start-ups, and understand how to best scale quality and risk management programs to fit the unique needs of each client, as well as their products and business objectives.
Some of our services include:
- Audits/Gap Assessments to: FDA 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485:2016, ISO 9001:2015 Standards, Medical Device Regulation 2017/745 (MDR) and Medical Device Single Audit Program (MDSAP). Assistance in resolving identified gaps
- Change Control, Corrective and Preventive Action (CAPA), including Root Cause Analysis
- Design Control Procedures, Implementation, Record Development and Audits
- Device Master Record (DMR)
- Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA) and Preliminary Hazard Analysis (PHA)
- Health Hazard Evaluation (HHE)
- Internal Audits
- Medical Device Product Design History File Development and Gap Assessment
- Medical Device Standards Assessment
- Mock FDA QSIT Inspection
- Process Validation (IQ/OQ/PQ)
- Risk Management Plan and Report
- Risk Management Program Development and Implementation, per ISO Standards
- Risk Analysis (ISO 14971:2019)
- Supplier Audits