Items tagged with FDA

Risk Management - Advanced Product Planning for Industry

Friday, 07 March 2014
ASR Editor
Risk Management is part of ISO 13485:2003 and AS9100 Rev C.

These two standards need to be fully understood before an effectively implemented system can be developed. Some  type of risk management plan might be valuable for all manufacturing and service industries.

Medical Device Makers and Component Suppliers Software Validation Reminder

Thursday, 15 November 2012
Rand E. Winters - ASR Senior Auditor
Medical device manufacturers will want to review their QMS documents to ensure they are addressing software  validation requirements.

ISO 9001:2008 -7.5.2.1 and the FDA requirements in 21 CFR 820.30 and 21 CFR 820.70i spell out validation requirements for software design as well software in the production environment.

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Automotive

  • IATF 16949
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Medical Devices

  • ISO 13485
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