New
Certification
Medical Device QMS & EU MDR (Team Package)
About this Course
Build an ISO 13485 quality system and meet MDR obligations across the device lifecycle.
A team package: bought once by your company and used by every colleague who needs it, from 3 participants. Delivered as live virtual, workshop, assessment, with 4 modules and about 12 hours of training per participant.
See plans, the buying process and how to request a proposal on the Team Training Packages page.
What You Will Achieve
This package covers:
- ISO 13485 quality management system
- Risk management under ISO 14971
- EU MDR technical documentation and clinical evaluation
- Post-market surveillance and vigilance
Target Audience
Device QA/RA, design engineers, post-market surveillance.
Bookable for teams: Team plan (3–9 participants), Department (10–24), Enterprise (25+) or In-house at your site.
Program Outline
| Module | Topic | Duration |
|---|---|---|
| 1 | ISO 13485 quality management system | ~3 h |
| 2 | Risk management under ISO 14971 | ~3 h |
| 3 | EU MDR technical documentation and clinical evaluation | ~3 h |
| 4 | Post-market surveillance and vigilance | ~3 h |
Registration Fee
Price on request
30-Day Money-Back Guarantee
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Start Date Dates to be announced
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Location Team Package
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Language English
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Certificate Official Certificate of Completion