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
FROM CONCEPT TO POST-MARKET, DELIVERING SIGNIFICANT TIME SAVINGS COMPARED TO INDUSTRY AVERAGES
HELPING medical device SPONSORS IMPROVE HEALTHCARE SINCE 1967
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.
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.
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.
Health Canada and FDA eSTAR Pilot
On January 10, 2023, the U.S. Food and Drug Administration (FDA) and Health Canada announced a new joint pilot program. This program will conduct tests on the use of FDA’s eSTAR to make a single medical device submission to both FDA and Health Canada.
The Value of Economic Data in Payor Engagement
Economic data can be any data that tells a utility or benefit story. It can include health economics and outcomes research (HEOR) which measures and generates evidence of a product’s value and impact to support reimbursement and market access. But, for purposes of this blog post, we will use the term ‘economic data’ more broadly than the term HEOR.
MDR Update: EPSCO Proposes Transition Improvements and EU Commission Issues MDCG 2022-18
At the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) meeting on 9 December 2022, EU Member States unanimously agreed that actions should be taken to ensure that the supply of medical devices is maintained during the Medical Device Regulation (MDR) transition period. Specific issues regarding Notified Body capacity and ongoing expiration of the EU’s Medical Device Directive (MDD) certificates during transition were the main concerns.
EU Commission Publishes MDR Implementing Regulation for Devices without Medical Purpose (Annex XVI)
In an important step forward for EU manufacturers of devices without a medical purpose, the final version of the ‘Implementing Regulation’ containing the common specifications related to the Medical Device Regulation (MDR) have been adopted.
Auditing a QMS According to ISO 13485
Medical device manufacturers must first ensure that their QMS conforms to the specified requirements and is effectively implemented and maintained. On the path towards ISO 13485 certification, manufacturers should undergo an internal audit and then an external certification audit. This article supports manufacturers in understanding the auditing process toward ISO 13485 certification.
Let NAMSA’s medical device development experts guide you in the right direction.