To improve the overall safety and performance of medical devices, the United States FDA has proposed an amendment to the Code of Federal Regulations (CFR) for 21 CFR4 Part 820 of the current good ...

Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post. The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed ...

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The FDA issued a final rule which continues efforts to promote consistency in the regulation of devices and provides timelier introduction of safe and effective high-quality devices for patients.

This course is organized to align with the organization of the subparts and paragraphs as presented in the QSR. This course is organized to align with the organization of the subparts and paragraphs ...

This is the On-demand recording of The RAPS Philadelphia Chapter’s webcast covering 21 CFR 820 quality system regulation and ISO 13485 medical devices. All medical device manufacturers supplying ...

Polymicro Technologies, a subsidiary of Molex, announced its registration and compliance with the U.S. Food and Drug Administration 21 CFR 820 Quality System Regulation. The Polymicro Technologies ...

Design for six sigma (DFSS) is both a business management tool and a product development process. It uses metrics, data and statistics, team dynamics, risk management, and project management tools.