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EU MDR risk management requirements: FMEA and ISO 14971 comparison
Historically, medical device manufacturers have frequently used Failure Modes and Effects Analysis (FMEA) to identify possible failures in
Summary of Safety and Clinical Performance (SSCP/SSP)
The Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostics Medical Device Regulation (EU) 2017/746 (hereinafter referred to as MDR and
Roadmap to CE marking for medical devices and IVDs
Placing medical devices (MD) and in vitro diagnostic medical devices (IVDs) on the market is not an easy and short path. It takes years until the
The quality management system according to ISO 13485
As a general obligation under the EU regulations, manufacturers pursuing to place medical devices into the EU market shall “establish, document,
Safety reporting for clinical investigations under the MDR
Safety reporting is a crucial aspect of a successful clinical investigation for medical devices. In addition to the Good Clinical Practice (GCP),
What are the requirements for a clinical evaluation for legacy and well-established technology devices?
Following the publication of the MEDDEV 2.7-1 in 2016 rev 4 and subsequently Medical Device Regulation 2017/745 (MDR), medical device manufacturers
Classification of software under MDR and IVDR
Software as a medical device or in-vitro diagnostic device (part I) Over the past years, software has become an essential tool in healthcare
Does the MDR mean the end of the equivalence route for clinical evaluations?
The concept of equivalence in the European’ MedTech sector In Europe, medical device manufacturers with products on the market have long used
Do You Need a Transition Strategy from MDD to MDR?
If you are failing to plan, you are planning to fail. It is crucial for all medical device manufacturers, as part of their business strategy,
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