2 Day EU MDR Training - INDIANAPOLIS, IN - MAY 5-6, 2021 - Join us In Person or Virtual
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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

Location: Date:

Indianapolis, IN May 5-6, 2021

Venue TBD Program runs 8:30 AM – 4:30 PM

Program Details:

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.

Course Agenda:

Day 1 EU MDR QMS Implementation

  • Overview, PRRC, Economic Operators
  • UDI/EUDAMED
  • Obligations of the Manufacturer – QMS Updates
  • Vigilance, FSCA
  • Classification

Day 2 MDR regulatory aspects including TF/Clinical requirements

  • Technical- Documentation
  • GSPR
  • Clinical Evaluation, PMS, PSUR, PMCF Activities
  • SSCP
  • Conformity Assessment/ BREXIT

Cost:

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 attendees

Register Here
Date & Time
Wednesday May 5th, 2021 7:30am CDT
End Date & Time
Thursday May 6th, 2021 3:30pm CDT
Categories
Conference, Webinar
Host Type
Technical
Category Public Calendar

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Date & Time: 05/05/2021 08:30:00 AM EDT