Quality Training

Medical Device Regulation Overview

Objectives

The 2-day course on MDR is highly interactive with many team exercises and discussion. Some of the specific topics covered include the following:

• Device and product families MDR implications
• Introduction to MDR Manufacturers Article
• Classification Documentation Changes
• Conforming with MDR UDI
• Clinical Investigations Vigilance and PSUR/PMS
• Safety Performance Labelling
• Authorised Representative MDR Audits and Inspection readiness
• Eudamed and MDGC Distribution
• MDR and other Certifications / Regulations

  Content includes

  The legislation outlining the requirements for medical device manufacturers prior to placing them on the market in the European Union is changing. The old Medical Devices Regulation (EU 2017/745) is to be replaced by the Medical Devices Directive (93/42/EEC). The new regulations place greater emphasis on accountability for all players and with greater scrutiny of both clinical evaluation and post-market clinical evaluations and improved traceability of devices for the full life cycle.

Who should attend

This training is aimed at those with a working knowledge QMS from all levels within the organisation including (but not limited to): • Authorised Representatives
• Manufacturing personnel
• Quality
• Regulatory Affairs
• Design and Development
• Economic Operators for example importers and distributors

Qualification

This course is not available for individuals, there is a minimum trainee requirement of 10 people.

Upcoming dates:

No training dates available at the moment.