The genae
difference
Expertise
Innovation
Scope
Partnership
Value
genae’s expertise covers a broad range of therapeutic areas. The knowledge and understanding of the specific area of your therapy or device ensures compliance and facilitates in the actual conduct of your trial.
Your advantage of working with genae is captured in our extensive experience in the central coordination and logistics of clinical research projects.
genae’s mission is to improve health and quality of life by innovating and accelerating high quality research – with a zealous dedication to safety and ethics.
With local anchoring, we aim at accelerating high-quality and cost-contained recruitment and execution of your global medical device trials.
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genae updates  

 
 

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).

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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.

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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.

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