Medical Device Regulations (MDR) Training 1 day programme
IntroductionIrish Medtech Skillnet in association with Irish Quality Centre (IQC) offer a one day Medical Device Regulations (MDR) Training. This one day event focuses on 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 postmarket clinical evaluations and improved traceability of devices for the full life cycle.
Content includesThe 1-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
- MDR implications
- Manufacturers Article
- Documentation Changes
- Vigilance and PSUR/PMS
- MDR Audits and Inspection readiness
Who should attendThis training is aimed at those with a working knowledge QMS from all levels within the organisation including (but not limited to):
• Manufacturing personnel
• Regulatory Affairs
• Design and Development
• Economic Operators for example importers and distributors Course
No training dates available at the moment.