Accreditation of MDQMS (ISO 13485) Certification
Accreditation of medical device quality management system (ISO 13485) certification bodies using ISO/IEC 17011, ISO/IEC 17021 Part 1 and IAF MDs
Your Instructor
Course Curriculum
Accreditation of MDQMS (ISO 13485) Certification
Available in
days
days
after you enroll
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StartAgenda
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StartDay 1: Overview of 13485, IAF MD 8 and 9, ISO 13485 Clause 4 (slides)
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Start1. Welcome and Introduction (video) (8:59)
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Start2. General Understanding of Medical Devices & ISO 13485:2016 (video) (80:36)
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Start3. Overview of IAF MD8+9. Management of Impartiality (video) (23:14)
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StartDay 2: ISO 13485 Clauses 5 - 8 (slides)
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Start4. Clause 6 (video) (40:28)
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Start5. Competence of Personnel (video) (34:59)
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Start6. Clause 7 - 7.2 (video) (34:14)
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Start7. Technical Areas (video) (54:48)
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Start8. Clause 7.3 - 7.5 & 8 (video) (39:43)
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Start9. Exercises (video) (8:14)
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StartDay 3: ISO 13485 Clause 9 - 10 and final Q&A (slides)
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Start10. Clause 9.1-9.2. Exercises (video) (38:27)
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Start11. Clause 9 (video) (70:42)
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Start12. Clauses 9.4 - 9.9 (video) (51:40)
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Start13. Clause 10 and wrap-up (video) (12:39)
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StartWorkshop exercises
Frequently Asked Questions
When does the course start and finish?
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What if I am unhappy with the course?
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