Is Integra’s Breast Reconstruction PMA Doomed?
Despite getting shot down by a recent FDA advisory panel, Integra’s management team still seems confident that the agency will ultimately approve SurgiMend for post-mastectomy breast reconstruction……
Localizing Medical Device Content for Global Markets
Is linguistic quality assurance a necessary requirement or an additional bottleneck for medical device companies?……
Changing Medical Device Regulations in the United Kingdom and in Europe
A look at how medical device companies can meet the need for a UK Responsible Person……
Mitigating Risk Through Quality Management in Medical Device Manufacturing
Consider these 4 steps when developing a quality management strategy…….
Secure by Design: Developing Cybersecure Medical Devices
As software-based medical devices become increasingly connected, cybersecurity must be considered right from the first design stages in order to protect patients’ health and personal data. However, in many instances there are no standards or clear guidelines for the medical sector……
An Ingredient List for Your Medical Device?
FDA seeks feedback on medical device content labeling……
One Year After EU MDR Delay, Plenty of Barriers to Compliance Remain
Manufacturers continue to face a lack of clarity, high costs, and manual processes in order to comply with the new medical device regulation (EU MDR), according to a recent survey. These results come one year after the regulation’s postponement and a few weeks before the new validity date……
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Chemical Compliance Requirements for EU MDR and IVDR
Is your medical device or diagnostic in compliance with this small, but essential, sub-section?……
What Are the Biggest Changes under EU MDR?
With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements……
European regulators publish new Q&A on custom-made medical devices
The European Medical Device Coordination Group (MDCG) has issued a new document covering key questions and considerations regarding custom-made medical devices in the context of Medical Devices Regulation (MDR) compliance……
