Getting ready for Europe’s new MDR - Clinical Evaluation
06 April 2017
The European medical regulatory landscape is undergoing its most significant overhaul in years. The eagerly-awaited Medical Device Regulation (MDR), expected to be published in Q2 2017, will bring substantial changes to the way medical device manufacturers bring their devices into the European market. At the heart of the current Medical Device Directive review lies the subject of the clinical evaluation. Our latest white paper guides you through nine important factors for the successful planning, development and maintenance of a Clinical Evaluation Report (CER).
The MedTech Strategist Innovation Summit - Dublin
25 April 2017
This exceptional investment and networking event – recognized by the medical device industry as the leading medical technology investment forum in Europe – is taking place April 25th through 27th, 2017, at the historic and centrally located Shelbourne Hotel, Dublin, overlooking St. Stephen’s Green.
Clinical Regulatory and Safety services
21 April 2017
genae provides a full range of regulatory support services for your pre- and post-marketing medical device development needs. Our experts adopt best practices while remaining on top of the ever-changing regulatory landscape.