This course provides instruction on the Medical Device Regulation 2017/745, with a focus on Medical Device Manufacturer requirements. It covers every aspect of the regulation and identifies key topics, including economic operators and roles associated with EU MDR, standard requirements for all manufacturers, and the pre- and post-market requirements of conformity assessment. Through lecture and classroom exercises participants receive an overview of MDR, Implementation Timelines, Paths to CE Mark, and a deep dive into articles that affect medical device manufacturers. Training is designed for Regulatory Affairs professionals unfamiliar with EU MDR and Regulatory Affairs personnel. It is available on-site at your organization and virtually.
Training Subtype:
Quality Control
Location:
319 Littleton Road #206
Westford, MA 01886
[On-site at Employer Location]
Program Results In:
Certificate
Course Length:
1 week(s)
Average No. of Hours/Week:
24 Hrs
On-line Course Schedule:
Cost/Student:
Includes:
$12,975.00
Tuition
Flat Rate Course:
(The cost of this course is based on a flat fee, regardless of the number of employees attending the course)
Yes
Performance Summary
Program Year (Most Recent):
For assistance, you may contact the MassHire TrainingPro Help Desk at 617-626-5003.
