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Insulation between opposite terminals of battery
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IEC 60601 - Medical Electrical Equipment Safety Standards Series
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Document Control Systems, Procedures, Forms and Templates
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Is this a medical device?
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Are there Controlled Documents in a DMR (Device Master Record)?
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ISO 13485:2016 - Medical Device Quality Management Systems
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Latest resources

Part IV : How to build a Lean, FDA/ISO 13485-compliant eQMS using an eDMS
FDA/ISO 13485-compliant eQMS using an eDMS
- Simon Roberts
- Updated: Thursday at 4:32 AM
Part III The guide to GxP Compliance
Medical Device GxP Compliance
- Simon Roberts
- Updated: Aug 23, 2022
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Acceptance Inspection Sampling Plan Calculators
Sampling Plans
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- Updated: Aug 1, 2022
Part II The guide to Medical Device GxP Compliance
GxP compliance
- Simon Roberts
- Updated: Jul 27, 2022
Part I : Guide to document control for Medical Device companies
Document Control
- Simon Roberts
- Updated: Jun 28, 2022

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Courtesy links Elsmar Cove visitors will find useful in the quest for knowledge and support:

International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

IEST - Institute of Environmental Sciences and Technology