Apply Post Market Surveillance, Risk Management and Vigilance requirements under the EU MDR and IVDR with confidence
The PMS requirements of the EU MDR and EU IVDR apply to all manufacturers of medical devices since May 2021 and from May 2022 respectively, even those who continue to place legacy devices on the market (devices certified under the AIMDD, MDD or IVDD). However, due to the postponement of EUDAMED implementation, all medical devices will continue to be subject to some of the provisions of the directives, including those that have achieved CE marking under the new Regulation.
Using a combination of theory and practical case studies, this course will clarify the transition of old requirements to new ones and will support delegates in developing the knowledge needed to build successful PMS strategies and understanding the latest requirements and technologies for reporting vigilance.
What will you learn?
Post Market Surveillance Strategies
Build successful PMS strategies to protect device sales revenues
Gain a clear understanding of your responsibilities as a manufacturer to ensure compliance with the requirements of the new Regulations
Cut through the confusion arising from the delayed release of the vigilance and market surveillance module of EUDAMED and the application of the new requirements for legacy devices
Adverse Incidents Management
Ensure you know how to best manage adverse incidents
Post Market Surveillance Challenges
Be prepared to meet the challenges of globalised PMS and emerging technologies
Live Online Training Course
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment.
Over 2 days students will learn through:
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including group discussion, case studies and Q&A
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions two days prior to the course start date. If you have any questions please contact Filippo.Scovasso@informa.com.
Who is this course for?
This course is relevant to medical device and IVD regulatory affairs professionals who wish to develop their understanding of PMS and vigilance:
- Post Market Surveillance
- Regulatory Affairs
- Global Regulatory Affairs
- Safety specialists
- Compliance Managers
- Quality Assurance
- Quality Compliance