ISO 13485:2016 - Medical Device Quality Management Systems

ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
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Particulate On Final Implantable Devices
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Alf Gulford
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Looking at 21 CFR 820.20 which calls out in section (d) for Quality Planning
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Alf Gulford
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I would like to know the requirements for USFDA approval
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QualPro
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QSR Purchasing Controls governing evaluation and use of consultants
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Don Winton
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Passivation Validation - Is passivation is considered a "special" process by the FDA?
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Don Winton
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Continuous Certification - ISO 9001 Certified EN4600 - Why the 3 year recert audit?
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barb butrym
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Verification Activities - Clinical Medical device manufacturer
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Don Winton
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Process monitoring - Stationary and portable oxygen units
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Marc
Marc
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Purchasing Procedure - QSR ?820.50 and ISO 9001:1994 Clause 4.6
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Don Winton
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Marc
Systems Requirements Mandated by EN46001 and EN46002
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Marc
Marc
Marc
Medical Device Industry Links
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TomS
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Classification rules for Canada - Electrosurgical and Cryosurgical Equipment
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Don Winton
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Marc
The Don Winton Memorial FDA Stuff Archive
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Marc
Marc
Marc
FDA has auditing guidelines posted on it's web pages for QSR
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Marc
Marc
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