Over the course of these 2 days, the attendees will learn about the new requirements to plan an efficient transition and ensure they are ready to:
Address the new Quality Management System (QMS) requirements;
Understand the IVD Product Classification criteria’s and Conformity Assessment routes and how it applies to their IVD device(s);
Assess the impacts on the Technical Documentation for In Vitro Diagnostic Medical Devices in relation with Product Classification criteria’s and Conformity Assessment routes;
Identify the expectations with respect to the Clinical Data(s), Clinical Performance Evaluation(s) and Risk Management;
Implement the requirements for labelling , the Unique Device Identification (UDI) and EUDAMED;
Address the expectations with respect to the requirements pertaining to the Post market Surveillance and Vigilance reporting (Periodic reports etc.);
About the Trainer
Medical Device Lead Auditor
Jawad Mahdavi is a senior medical device lead auditor. He brings to GMED North America with a reservoir of technical and regulatory knowledge through his various experiences from working in innovative and International environments. Jawad holds various professional certifications. In addition to serving as a medical device lead auditor for GMED NA, Jawad routinely participates as a training instructor for regulations surrounding IVD devices.
Fully owned subsidiary of GMED SAS. • GMED, Notified Body n° 0459
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