The PMS requirements of the Medical Device Regulation (MDR) apply to all manufacturers of medical devices from May 2020, even those who continue to place legacy devices on the market (devices certified under the AIMDD or MDD). However, because the implementation of Eudamed (the European database) has been postponed, 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 allow delegates to develop the knowledge needed to build successful PMS strategies and understand 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 postponement of Eudamed and the application of the new requirements on legacy devices
Adverse Incidents Managements
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
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:
- Regulatory Affairs
- International Regulatory Affairs
- Safety specialists
- Compliance Managers
- Quality Assurance
- Quality Compliance
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.
25% discount on Routledge books
As a student on the course you will receive a 25% discount on any Routledge books or eBooks. To view the full product range visit the Routledge website www.routledge.com.
Examples of books and eBooks within medical devices include:
- ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, Second Edition
- ISO 9001: 2015 - A Complete Guide to Quality Management Systems
- Medical Device Quality Assurance and Regulatory Compliance
- Medical Device Regulatory Practices: An International Perspective
- And more