NAMSA is the World’s leading medtech cro offering global end-to-end development services…
DRIVEN BY ITS GLOBAL REGULATORY EXPERTISE AND IN-DEPTH THERAPEUTIC KNOWLEDGE…
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HELPING medical device SPONSORS IMPROVE HEALTHCARE SINCE 1967.
Driven by our global regulatory expertise and in-depth therapeutic knowledge, NAMSA offers only the most proven solutions to move your medical device through the development lifecycle as efficiently and cost-effectively as possible.
Offering product development strategy; medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, we are dedicated to helping you achieve accelerated, successful development and commercialization outcomes.
Gain 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.
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 what recent news means for your medical device development plans and commercial operations.
New Implementing Regulation Released to Provide Guidance on Electronic Instructions for Use (eIFU) under MDR
On 14 December 2021, the European Commission published a new Implementing Regulation, (EU) 2021/2226, explaining the rules regarding the application of the Medical Device Regulation (MDR). Specifically, this document highlights the provision of electronic instructions for use (eIFU) for medical devices, which came into force on 4 January 2022.
European Commission Releases Further Harmonised Standards under EU MDR
The New Year saw the European Commission (EC) publish a second batch of harmonised standards under the EU MDR. Commission Implementing Decision (EU) 2022/6, released on 4 January 2022, amends the earlier Implementing Decision (EU) 2021/1182 published in July 2021. It introduces a further nine harmonised standards that medical device manufacturers should reference to satisfy conformity requirements under the MDR.
FDA Issues COVID-19 Transition Plans for EUA and Enforcement Actions
Following the declaration by DHS of the COVID-19 Pandemic, the FDA began to issue Emergency Use Authorization (EUA) approvals and enforcement policies for devices used to mitigate the spread of the SAR-CoV-2 virus, including the diagnosis, treatment or prevention of Coronavirus Disease (COVID-19). On, December 23, 2021, the Agency acknowledged the general need for a transition process back to ‘normal operations’ and released two draft guidance documents that introduce their proposed transition plans.
FDA Releases 3D Printing at the Point of Care Discussion Paper
FDA Announces Release of “Playbook for Threat Modeling Medical Devices”
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