This course provides training on effective risk management for medical devices and includes important changes from the EU Medical Device Regulation and the MDSAP approach to risk. Through lecture and classroom exercises participants learn global regulatory compliance requirements for risk management, including FDA and EU; purpose/scope/contents of ISO 14971:2019 and ISO/TR 24971; requirements for each step of the risk management process; and post-production risk management requirements. Training is designed for design managers and engineers; manufacturing, service, QA, reliability, R&D, and regulatory affairs professionals; and other medical device team members. Training 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:
$9,975.00
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.
