Developing and bringing a medical device to market is a scary process. Not only do you have to come up with a great idea or design improvement and develop a working prototype, but you must also ensure the device is safe and performs as intended in an...
Medical devices have one purpose: to improve the life of patients. They are developed with this purpose in mind, and the entirety of regulatory compliance is designed to ensure that medical devices remain safe and perform as intended throughout their...
When the updated European Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostic Regulation (IVDR, 2017/746) were issued in 2017, the European Commission increased the requirements for monitoring the behavior of medical devices in the mark...
Recently, our Scilife CEO Filip invited Mika Siitonen, Medical Development Manager at Labquality and seasoned expert in medical device regulatory guidelines, to answer anything and everything you wanted to know about performing Risk Management under ...
A fundamental part of safeguarding patients in Europe comes from ensuring that medical devices and in vitro diagnostics (IVDs) meet consistent, high regulatory standards. Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation...
The EU medical device regulatory framework continues to evolve. As EUDAMED modules roll out and MDR timelines shift, many manufacturers are finding that maintaining compliance now requires far more structure and oversight than it did just a few years...
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