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NAMSA
IVD

UNIQUELY IVD: Built for the unique
needs of IVD SPONSORS

Let our dedicated In Vitro Diagnostics Team take the guesswork out IVD development and regulatory compliance.
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200

IVD Studies Supported

100

Global Regulatory Submissions

500

IVD Trial Sites Managed

15

Monthly IVDR Tech file assessments

EU IVDR COMPLIANCE COUNTDOWN

IVDR

22
Months
13
Days

NAMSA’s stand-alone IVD business unit, the only within the Contract Research Organization (CRO) industry, is focused on meeting the unique product development needs of IVD manufacturers. We help clients fast-track the commercialization of life-changing IVD products through our proactive approach and in-depth knowledge of IVD requirements.

We not only understand how to accurately interpret the complicated regulatory challenges that IVD manufacturers sometimes face, but we also help you simplify the development and implementation of effective development strategies. Whether supporting IVD regulatory assessments and submissions, developing IVDR compliant technical files, designing and managing clinical trials or building ISO 13485:2016 and 21 CFR part 820 compliant quality systems… we’ve got you covered.

Our IVD experts partner with your team on a global scale and in a variety of capacities. Some clients choose to outsource all regulatory, quality, reimbursement and clinical research initiatives, while others collaborate with us on portions of their IVD regulatory or clinical study processes. No matter your needs, NAMSA is the most flexible IVD CRO in the industry and we pride ourselves on delivering high-quality results by leveraging our collective global expertise. We partner with you every step of the way to ensure your success.

 

IVD Clinical Research, Biostatistics & Data Management Services

Our Data Managers understand the nuances of collecting instrument and sample/subject data for IVD trials and can effectively manage the most critical asset–your data–as you collect and report clinical study outcomes for submissions in the U.S., China, Japan, Europe and other key geographies.

Our team supports studies of various types and phases including: Feasibility, Pilot, Usability/Human Factors Evaluation, Validation, Post Market Surveillance and Post-Market Performance Follow-up, Limit of Detection, Clinical Performance and Reproducibility.

NAMSA offers the following IVD clinical research, biostatistics and data management services to expertly guide you through the clinical trial phase:

– Biostatistics
– Central Lab Management
– Clinical Audits & Bioresearch Monitoring (BIMO) Audit Support
– Clinical and Biostatistical Discussions with Regulatory Bodies
– Clinical Studies to Support IVDR
– Database Development and EDC management
– Data Review and Management
– Kit Management
– Monitoring
– Protocol Development
– Sample/Specimen Collection
– Site Close-Out Visits
– Site Selection/Qualification
– Site Start-Up and Training
– Statistical Data Analysis and Reporting
– Statistical Study Design
– Trial Master File Set-up and Maintenance

IVD Regulatory Services

Unlike other industry Contract Research Organizations (CROs), NAMSA’s IVD Team has expertise with hundreds of successful regulatory submissions throughout North America, China, Japan, Europe and other parts of the world. As a result, our team has near daily interactions with international regulatory authorities and understands how to properly translate current regulations and expectations into successful strategies, while also anticipating challenges and de-risking IVD product development initiatives.

NAMSA’s IVD Team supports the following regulatory strategy and submission initiatives:

U.S.
– 510(k)
– Biologics License Application (BLA)
– Clinical Laboratory Improvement Amendments (CLIA) Waiver
– De novo Submission
– Device Master File
– Emergency Use Authorization (EUA)
– Investigational Device Exemption (IDE)
– Premarket Approval (PMA)

EMEA
– CE Mark
– Design Dossier/Technical File Review or Build
– In Vitro Diagnostic Directive (IVDD) to In Vitro Diagnostic Regulation (IVDR) Transition
– Performance Evaluation Plan (PEP)/Performance Evaluation Report (PER) Gap Assessment and Reporting

China
– Legal Agent
– National Medical Products Administration (NMPA) Product Classification and Registration
– NMPA Consulting
– NMPA Submission, Follow-Up and Secure License
– Type Testing Preparation, Submission and Oversight

Japan
– Pharmaceuticals and Medical Devices Agency (PMDA) Product Classification and Registration
– PMDA Consulting
– PMDA Submission

Canada
– Health Canada Consulting
– Health Canada Product Classification and Registration
– Health Canada Submission

IVD Reimbursement Support Services

NAMSA offers a full continuum of reimbursement services and solutions for new and existing IVD technologies. Our teams are expert in all aspects of reimbursement strategy and payer relations, including:

– Coverage Advocacy
– Healthcare Common Procedure Coding System (HCPCS) and Current Procedural Terminology (CPT) Code Analysis/Applications
– Health Economic Analysis
– Medical Policy Research
– National and Local Coverage Determination Coverage Policy
– Payer Perspective Analysis Brief
– Payment Strategy

Customer Segments Served:
– Physician Office
– Laboratory Testing
– Hospital/Bundled Payments

IVD Quality Systems Services

NAMSA employs the IVD industry’s premier quality experts to effectively design Quality Management Systems (QMS) to ensure compliance with ISO 13485:2016, U.S. FDA CFR 21 part 820 and Medical Device Single Audit Program (MDSAP) certifications.

NAMSA’s team is skilled at transitioning IVD manufacturers from the EU’s In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) in the most effective, timely manner possible so you may effectively stay on the market. If you are unsure where to get started, NAMSA offers gap assessments to help identify needs and suggested strategies for compliance and to streamline business operations.

NAMSA delivers the following services to ensure quality compliance:

– Audit Support for MDSAP, ISO 13485:2016 and 21 CRF Part 820
– Corrective and Preventive Action (CAPA) Audits and Remediation
– Complaint Handling
– Design Controls
– Design History File (DHF) Development
– ISO 13485:2016 Transition
– IVDR Compliance, Planning and Tech File Development
– Mock Audits
– Procedure Development, Implementation and Training
– Quality Audits
– QMS Assessment and Gap Analysis
– QMS Development
– Risk Analysis, Failure Modes & Effects Analysis (FMEA), Fault Tree Analysis, Hazard Analysis
– Risk Management (ISO 14971: 2007 and EN ISO 14971: 2012)
– Risk Management Plans and Reports

IVD Therapeutic Expertise

The breadth of knowledge and application experience that NAMSA’s IVD Team possesses is enough to power even the most complex IVD program. We are the IVD industry’s CRO leader for regulatory, clinical research and quality system services for assays, disposable products, instruments, reagents and systems in several therapeutic areas.

Some of our most frequently requested IVD therapeutic areas includes:

– Clinical Chemistry
– Companion Diagnostics
– Direct to Consumer Testing (DTC)
– Drugs of Abuse Testing
– Hematology
– Hemostasis/Coagulation
– Histology and Cytology
– Immunochemistry
– Microbiology Culture
– Molecular Diagnostics
– Point of Care Testing

IVD Client Testimonials

“We required a high level of confidence in the data that we would ultimately be putting in front of the U.S. FDA. Working with NAMSA provided this measure of confidence.”
– U.S.-Based IVD Start-Up Manufacturer, Clinical Affairs Manager

“NAMSA’s team had the best grasp of IVDR. We are extremely satisfied with the quality of work.”
– Global Tier 1 IVD Manufacturer, Regulatory Affairs Specialist

“We were pleased with the level of knowledge and rationale to classify our novel IVD technology per the Chinese classification system. Hiring NAMSA was one of the best decisions to get our product into the China marketplace. They helped us ease our fears given that we did not have a legal entity in China.”
– U.S-Based IVD Start-Up Manufacturer, Senior Vice President

“NAMSA’s templates for PEPs and PERs are thorough. In the event we requested modifications, the team was able to quickly adapt to our requested style.”
EU Mid-Size IVD Manufacturer, Regulatory Affairs Manager

Resources

Literature
NAMSA Start-Up 360: Accelerating IVD Product Development
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Guide
NAMSA Guide: How to Design & Develop EDC Systems for Optimal IVD Clinical Trial Management
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Webinar
Optimizing Electronic Data Capture (EDC) for IVD Clinical Trials
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Guide
NAMSA Guide: In Vitro Diagnostic (IVDR) Readiness Guide
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Webinar
Do’s & Don’ts for Early-Stage IVD Product Development & Risk Mitigation
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