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GLOSSARY PAGES
IN DEPTH DESCRIPTIONS OF SOME OF THE MOST IMPORTANT TERMS RELATING TO MEDICAL DEVICE QUALITY AND REGULATORY
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EU MDR
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MEDDEV 2.7/1
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FDA QSR
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510k vs PMA
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FDA 483
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Quality Assurance vs Quality Control
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ISO 13485 Standards
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ISO 13485 Certification
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Design Controls
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Medical Device Classes
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Medical Device Design Verification
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What is DHF (Design History File)?
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What is Device Master Record (DMR)?
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What is Device History Record (DHR)?
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ISO 9001
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Quality Management Tools
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CE Marking
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ISO 14971
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Corrective and Preventive Action (CAPA)
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ISO 13485
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510K Submission
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21 CFR 820
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21 CFR Part 11
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QMS (Quality Management System)
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Quality Assurance (QA) Systems
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