Medical Device Quality Management Systems and Procedures

QMS products to support medical device design and manufacturing activities.

MEDICAL DEVICE QUALITY MANAGEMENT SYSTEMS

The ISO 13485 QMS procedure bundles contain multiple quality system procedures that govern a particular subject or ISO 13485, DFA QSR, or MDR 2017/745 requirements. The procedure bundles, and related forms, are in MS Word and Excel formats.

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ISO 13485 QMS Procedure Bundles

The ISO 13485 QMS procedure bundles contain multiple quality system procedures that govern a particular subject or ISO 13485, DFA QSR, or MDR 2017/745 requirements. The procedure bundles, and related forms, are in MS Word and Excel formats.

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Individual ISO 13485 QMS Procedures

Our individual ISO 13485 QMS procedures provide solutions for medical device companies needing to quickly address ISO 13485:2016, FDA QSR, or MDR EU 2017/745 quality system compliance gaps. The ISO 13485 QMS procedures are developed in either MS Word or Excel format and can be easily modified.

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Medical Device Validation Protocols

Medical device validation protocols for various medical device validation activities. Easy to modify MS Word format. Comply with requirements of ISO 13485 and FDA QSR.

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A. P. Lyon Medical Device Quality Management Systems and Procedudres

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