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NAMSA

NAMSA IS THE WORLD’S LEADING MEDTECH CRO OFFERING GLOBAL DEVELOPMENT SERVICES

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DRIVEN BY ITS GLOBAL REGULATORY EXPERTISE AND IN-DEPTH THERAPEUTIC KNOWLEDGE

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FROM CONCEPT TO POST-MARKET, DELIVERING SIGNIFICANT TIME SAVINGS VS. INDUSTRY AVERAGES

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HELPING MEDICAL DEVICE SPONSORS IMPROVE HEALTHCARE SINCE 1967

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Our Services

Driven by our global regulatory expertise and in-depth therapeutic knowledge, NAMSA is a medical CRO offering only the most proven solutions to move your medical device through the development lifecycle as efficiently and cost-effectively as possible.

As a medical contract research organization, we are dedicated to helping you achieve accelerated, successful development and commercialization outcomes. NAMSA’s offerings include medical device testing; regulatory, reimbursement and quality consulting; and clinical research services.

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Resources

Learn from the world’s leading medical CRO with complimentary access to our latest white papers, webinars, and other resources to learn proven strategies and best practices for successful medical device development and commercialization outcomes.

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Blog

Always on the pulse of industry news, we interpret the latest regulatory guidelines and other medical device updates so you don’t have to. Learn from the world’s most trusted medical device CRO to stay up-to-date on recent news and what it means for your medical device development plans and commercial operations.

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Real-World PMCF Under the MDR: Cost Effective PMCF Strategies and Plans

The MDR introduces more stringent requirements for medical device manufacturers, emphasizing patient safety and a clinical evidence-based approach to the confirmation of the benefit-risk determination for each device. Under the MDD, the term PMCF was associated with formal post-market studies and only considered necessary for a few high-risk or novel devices. Under the MDR, PMCF is an integral part of the post-market surveillance (PMS) process applicable for all devices. Another important change with the MDR is that PMCF is defined as a continuous process which updates the clinical evaluation. To place a product on the market in Europe under the MDR is therefore a commitment to continue to gather information, including clinical data, for the lifetime of the device. Further insights are available in the white paper on device lifetime co-authored by NAMSA and BSI.

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MDCG 2024-10 Clinical Evaluation of Orphan Medical Devices

MDCG 2024-10, published in June 2024, addresses the difficulties in generating clinical data for devices specifically intended for use in rare diseases/conditions or specific indications for rare cohorts of patients with non-rare diseases/conditions. The MDCG introduces the phrase orphan devices to identify those devices that have precise indications used in a small patient population where gathering sufficient pre-market clinical data can be challenging, particularly given the increased requirements of the Medical Device Regulation (MDR).

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FDA Releases "Transparency of Machine Learning – Enabled Medical Devices: Guiding Principles"

On June 13, 2024, the FDA, Health Canada, and the MHRA jointly published the “Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles | FDA.” This new publication has further identified guiding principles for transparency for machine-leaning -enabled medical devices (MLMDs)

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MHRA Statement of Policy Intent: International Recognition of Medical Devices

Explore the crucial role of benefit-risk determination in EU MDR compliance and common pitfalls to avoid in medical device evaluation.

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An In-Depth Exploration of Reimbursement Billing Guides and Their Benefits

Explore the crucial role of benefit-risk determination in EU MDR compliance and common pitfalls to avoid in medical device evaluation.

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