Introducing Medical Device Regulation (MDR 2017/745/EU)
Details
The MDR introduces numerous changes, including shift from pre-approval stage to life-cycle approach. It also incorporates European guidance documents (MEDDEVs) into the regulation and emphasizes the importance of Post-Market Surveillance (PMS), clinical data, clinical evaluation and Post-Market Clinical Follow-up (PMCF). MDR compliance presents many new challenges to medical device manufacturers.
Through this seminar, you will get an insight on the requirements of the MDR to better prepare your organization and your medical devices to transition smoothly to the MDR to continue to affix CE marking to your devices.
Outline
Agenda
- Introduction to MDR
- Classification of medical devices
- Conformity assessment procedure
- Technical documentation requirement
- General Safety and Performance Requirements
- Clinical data & clinical evaluation requirements
- Post-Market Surveillance, vigilance and market surveillance requirements
Speaker/s
Moira Lim is a Medical Health and Service auditor with TÜV SÜD Malaysia, who is responsible in conducting compliance audits of medical device manufacturers who are certified by TÜV SÜD Product Service.
Trained as a microbiologist, Moira Lim, has 9 years of experience in the manufacturing industry as well the laboratory testing industry with regards to both medical devices and pharmaceutical manufacturers.
As a Notified Body auditor, Moira Lim, primarily is assigned to perform audits according to regulations such as the Medical Device Directive of the European Union, the regulatory requirements as stipulated in the Medical Device Single Audit Program (MDSAP) and the ISO 13485:2016. She is part of the qualified trainers of TÜV SÜD Product Service who has been trained on the Medical Device Regulations (EU) 2017/745 of the European Parliament.
Special Offer
- 10% off for early bird registration before 16th Oct
- 20% off for group registration of 3 pax and above
Headquartered in Munich, Germany and founded in 1866, TÜV SÜD is one of the world's leading technical service organisations. Our main business activities are products testing, inspection, auditing and certification.
For more than 150 years, TÜV SÜD played the pivotal role of helping our partners turn innovative ideas into social realities. We focus on 4 strategic themes: Consumer Protection, Digital Transformation, Sustainable Development and Urbanisation which we believe will shape the narrative of commerce and society in the decades to come.
Today, we are represented by about 24,000 employees across more than 1,000 locations, partnering clients wherever they are in the world. Our community of experts is passionate about technology and is inspired by the possibilities of your business. United by the belief that technology should better people’s lives, we work alongside our customers to anticipate and capitalise on technological developments, enabling progress for businesses and the society.
Related Courses
