This In-house course gives an essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting.
This In-house course provides an essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting for medical device clinical studies complying with the European Medical Device Directive 93/42/EEC. It will provide a good introduction to medical device clinical studies and serve as an update for those with experience who need to keep abreast of the regulatory changes and the methods of handling adverse events during the study period.
Your team will:
Welcome and IntroductionThe regulatory requirements for monitoring and reporting Adverse Events during regulatory and Post Market Studies
Kath Clarke is an independent consultant to the Medical Device industry; she was previously the Regulatory Affairs and Quality Assurance Manager at Medvance, a Clinical Research Organisation.
She has a BSc in Chemistry and was previously a member of BARQA’s Medical Device Committee. She has also resided on two BSi Committees concerning Healthcare Standards.
She started her career in the Medical Device Industry more than 30 years ago, when she joined Smith & Nephew. During her time there she held a variety of QA and RA roles in numerous divisions covering various therapeutic areas. After leaving Smith & Nephew she moved to Tissue Science Laboratories, where she held the position of Regulatory Affairs Manager, her responsibilities being many and varied; including CE marking and product registration in global markets.