In a recent MD+DI webinar called, “Understanding the EU MDR”, which was sponsored by Accumold, Nelson Laboratories, and Oliver Healthcare Packaging, Dr. Bassil Akra, CEO of Akra Team GmbH, gave ...
PARIS--(BUSINESS WIRE)--Regulatory News: CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for ...
Currently, both existing CE-mark devices and devices hoping to be sold in the European Union (EU) face major challenges in the conformity assessment procedure for market access. During his session, ...
VIENNA, Feb. 5, 2026 /PRNewswire/ -- P&F Products and Features GmbH, a global heart valve MedTech company focused on transcatheter solutions for structural heart disease, today announced it has ...
The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.
Magstim Passes Compliance with Strict European Union Medical Device Regulations Expanding Magstim Access to Entire EU Marketplace WHITLAND, United Kingdom, May 16, 2025 (GLOBE NEWSWIRE) -- Magstim has ...
PARIS--(BUSINESS WIRE)--DentalMonitoring is proud to announce that the DentalMonitoring Software is now certified under the European Union Medical Device Regulation 2017/745 (EU MDR) and fulfills the ...
Can New Devices be Approved from Single Arm Studies: Use of Real-World Data as an External Control Group or for Propensity Matching or Generating Objective Performance Criteria Receive the the latest ...
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