This webinar will help you gain a better understanding of manufacturer responsibilities for clinical evaluation under the MDR, the clinical evaluation process including related Medical Device Coordination Group (MDCG) guidance on equivalence (MDCG 2020-5) and legacy devices (MDCG 2020-6), additional processes/documentation related to clinical evaluation and current experience in the MDR transition period.
The scrutiny of clinical evaluations by Notified Bodies has increased with the EU Medical Devices Regulation 2017/745 (MDR). This scrutiny leaves some companies at risk for observations and nonconformities when transitioning from the Medical Devices Directive 93/42/EEC (MDD) to MDR.
About the presenter:
Heather Crawford, senior consultant, Quality and Regulatory Affairs (North America), Emergo by UL
Heather Crawford has over 20 years of experience in the medical device industry, specializing in regulatory affairs and quality management systems. Heather’s background includes developing or contributing to 25+ Clinical Evaluation Reports, 25+ EU Technical Files/Design Dossiers, US Premarket Approval (PMA) applications, and 25+ US 510(k) submissions. Heather also has extensive experience in standards development and contributed to the US position on standards, including ISO 13485 and ISO 9001. As a Senior Quality and Regulatory Affairs Consultant, Heather works directly with clients on their quality and regulatory projects. She also peer reviews reports and regulatory filings for her colleagues. Prior to joining Emergo by UL, Heather worked in industry, focusing on implantable devices and new products.