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FDA Compliance

Clarifying the Risk Management Requirements of IEC 60601-1, Third Edition

August 4, 2006 7:17 am | Product Releases | Comments

Guidelines that aid medical device manufacturers in the regulatory approval process are welcomed resources for engineers. The third edition of the IEC 60601-1 integrates risk management into the previously accepted safety standards for medical electrical equipment.

LISTED UNDER: FDA Compliance | Medical Device Testing

Emphasis on Corporate Culture: Embracing Quality System Compliance in Corporate Culture

February 7, 2006 5:39 am | Proven Process Medical Devices | Product Releases | Comments

Corporate culture plays an enormous role on the productivity of a company's workforce, yet it is an aspect that is seldom considered as a method with which to improve efficiency.

LISTED UNDER: FDA Compliance | Medical Device Testing | Product-Safety/Performance Testing

Emphasis on QA/QC Streamlining Quality Assurance and FDA Compliance

May 3, 2005 7:27 am | Product Releases | Comments

AT A GLANCE • CARs and CAPA defined • 21 CFR Part II initiatives • Part 820's GMP

LISTED UNDER: FDA Compliance | Product Design

Tackling Compliance Reviews

January 5, 2005 9:20 am | Product Releases | Comments

Pressed for time, tight on resources, and eager to reach their target market wherever in the world it is, medical device manufacturers are embracing third-party compliance reviews.

LISTED UNDER: FDA Compliance | Microbiology/Chemical Testing | Medical Device Testing
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