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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We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States
Due to our rapid growth in North America, we're seeking Lead Auditors.