ASQ New England Biomedical in collaboration with CGH Associates:
European Medical Device Regulations Implementation
Class Presentation by: Nicohl Asher, Lead Medical Device Auditor
Debbie Iampietro, Lead Medical Device Auditor
Attend in person or virtual
Indianapolis, IN May 5-6, 2021
Venue TBD Program runs 8:30 AM – 4:30 PM
This 2-day class will provide an in-depth look at the key regulatory aspects along with QMS implementation of the European Medical Device Regulations (MDR). It will be of value to anyone working in the Medical Device community and anyone marketing or planning to market medical devices in Europe. The class will focus on implementation and participants will receive certification of completion, course materials along with a variety of procedure templates and checklists.
Day 1 EU MDR QMS Implementation
- Overview, PRRC, Economic Operators
- Obligations of the Manufacturer – QMS Updates
- Vigilance, FSCA
Day 2 MDR regulatory aspects including TF/Clinical requirements
- Technical- Documentation
- Clinical Evaluation, PMS, PSUR, PMCF Activities
- Conformity Assessment/ BREXIT
2 Day course: $2400.00. Includes: lunch and breaks each day as well as course materials.
Registration is limited to 30 people so please register early.
Course registrations deadline is April 23, 2021. No refunds after that date.
Room will be of sufficient size to accommodate for Physical Distancing
A signed Covid Waiver will be required of all attendeesRegister Here