Comply Guru offer courses that are more convenient, flexible, and effective way to learn about the new European Medical Device Regulation (2017/745).
The European Medical Device Regulation (2017/745) has replaced the Medical Devices Directive (93/42/EEC) as the legislation detailing the requirements that manufacturers must meet to place medical devices on the market in the European Union.
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Training Guide
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.
Blended
Exemplar Global 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.
eLearning
CQI & IRCA This course provides clarity on the role and responsibilities of the Person Responsible for Regulatory Compliance (PRRC) introduced under Article 15 of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).
Instructor-led Learning
Comply Guru This course is for those looking to understand the clinical evaluation requirements under the EU MDR (2017/745)
Instructor-led Learning
Comply Guru 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).
Instructor-led Learning
Comply Guru Comply Guru offer European Regulation Essentials Courses for organizations looking for a concise, high-level introduction for their staff.
eLearning
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