The release of MEDDEV 2.7.1 Rev 4 June 2016 on clinical evaluations in Europe led to the the principle challenges for device companies to ensure compliance to new requirements and making justification that the available data is sufficient to support the performance and safety of a device.

Clinical evaluation is a methodologically sound ongoing procedure to collect, appraise and analyze clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s instructions for use.

Part I of the webinar covers:

New Requirements for MEDDEV 2.7.1 Rev 4
Most significant changes in Rev 4
Evaluation of Risk-Benefits profile
Impact on the CERs & device companies
Process / Steps for you to consider

Speaker:

Dr. Frank Turner
Global Medical Director,
Director of Medical Affairs
SME National Institutes of Health

Date & Time: Thursday, 29th June 2017 , 11 AM -12 Noon EST | 5 PM - 6 PM CET

Click here to register : https://www.makrocare.com/webinar-registration-for-device-compliance-with-meddev-2-7-1-rev-4-for-clin-eval-cer