Medical Device Validation

An Introduction to Medical Device Validation – Part 1

This training program will be beneficial to all personnel directly involved in medical device validation, as well as new or seasoned operational personnel who will eventually participate in such efforts. Individuals in management who interact with validation or interact with regulatory agency inspectors to rationalize or defend validation programs will also benefit from taking this course. No experience of validation is necessary though some knowledge of processes would be beneficial.

CEU Credits: 0.1
Course Code: ELM-156
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0

Curriculum for this course

Course Overview
Learning Objectives
Who Should Take This Course?
Validation Vs Verification
Example of Verified and Validated
Product Life Cycle
USA – 21 CFR Part 820
EU MDR 2017/745
ISO 13485
GHTF 2004 Guidance – Process Validation
2009 - Poly Implant Prothèse (PIP) Breast Implants
2010 - DePuy Hip Replacement Recall
2012 - Stryker Modular-Neck Hip Stem Implants Recall
2012 - Batteries of Pacemakers and Implantable Defibrillators
2019 - Medtronic’s Product Recall of Implanted Cardiac Pacemakers
2019 - Injectable Cosmetic Treatments
Case Study One: Duodenoscope
Case Study Two: LVAD Pump Stoppage
Case Study Three: Pacemaker Hack
Case Study Four: FDA Warning Letter (21 CFR Part 820.75)

Conclusion

Final Assessment

Certification

Author

Don Hurd

Practical Quality & Thorough Validation The Realtime Group

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