This course will provide learners with the knowledge and skills required to perform audits of medical device quality management systems (MD-QMS) against the European Union’s Medical Device Regulation (EU 2017/745) in accordance with ISO 19011 and ISO 17021 as applicable.
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This course takes you through the new European Medical Device Regulation (2017/745), not just from an industry perspective, but also from a Notified Body perspective. It has been specifically designed for Quality & Regulatory Professionals who are new to the Regulation.
This course provides clarity on the role and responsibilities of the Authorized Representative under Article 11 and Article 12 of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).
Comply Guru offer European Regulation Essentials Courses for organizations looking for a concise, high-level introduction for their staff.
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