The position paper from the European Commission’s Medical Device Coordination Group (MDCG) recommends an extended timeline to allow certain MDD or AIMDD certified legacy devices to come into compliance with MDR.
Revised EU GMP Annex 1 requirements must be fulfilled by August 2023. Designed to protect and increase confidence in the sterility of these products, the new specifications are significant and wide-ranging, spanning the Quality system and the manufacturing process itself. Anna Cluet of Rephine discusses the practical specifics of designing and delivering a fit-for-purpose contamination control strategy.
Balwani was found guilty on 10 counts of wire fraud and two counts of conspiracy to commit wire fraud for misleading investors about the financial health of the healthcare startup. He faced up to 20 years in prison for each count.
EU MDR has increased the regulatory burden for medical device companies, but it can also serve as a catalyst for innovation and an opportunity to streamline clinical evaluation workflows through the adoption of digitalization and AI-powered automation.
In addition to challenges brought by new EU MDR, Switzerland has struggled to approve and introduce new devices due to its revised national medical device ordinance, which created even tougher import hurdles.
Baxter Hillrom is recalling its WatchCare Incontinence Management System (IMS) following reports that the radiofrequency emissions (RF) from WatchCare devices may interfere with other medical devices.
Holmes, who was found guilty in January on three counts of investor fraud and one count of conspiracy to commit fraud related to her blood-testing startup, faced up to 20 years in prison for each guilty count.
The guidance is intended to clarify the FDA’s approach for referencing the terms “device” and “counterfeit device” in FDA documents, as well as how the agency intends to interpret existing references to section 201(h) of the FD&C Act in guidance, regulatory documents, communications and other public documents.
Cybersecurity, remanufacturing of devices and chemical analysis for biocompatibility assessment of medical devices are among the topics FDA plans to address through draft and final guidances in 2023.
Mahofski will be responsible for identifying and pursuing acquisition opportunities that complement RQM+’s core regulatory services and provide a comprehensive range of fully integrated outsourced solutions to help get MedTech products to market faster and ensure ongoing regulatory compliance.