Basics and Significance of Product Code | #product code #medical devices #product code of medical devices

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Basics and Significance of Product Code

It is 3 letter code found on 510k clearance letters. Public information allows access to decide the type of submission for the device. Appropriate databases are provided by FDA to access product codes.

21 CFR Part 820 is set regulations issued by FDA which outline how to meet current good manufacturing practices (CGMP) standards for medical device makers within the United States must follow with regards to their quality systems. These CGMP regulations ensure that medical device manufacturers establish an effective QMS to ensure the production of effective, safe and reliable products...Read more at...https://www.i3cglobal.in/fda-qsr-21-cfr-part-820/

EN ISO 13485 Certificate | #iso 13485

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EN ISO 13485 Certificate

Implementing and maintaining a solid quality management system (QMS) for your medical devices, goods, and services is critical to your company's success. Your QMS's EN ISO 13485 accreditation displays your dedication to working at a worldwide level.

What is the result of not appointing an Authorized Representative? | #ec representative

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What is the result of not appointing an Authorized Representative?

Authorized Representative' means any natural or legal person based in the Union who has been given an authorized written order from the manufacturer located outside the Union acting on behalf of the manufacturer in regards to specific tasks with regards to the manufacturer's ob

What is the result of not appointing an Authorized Representative? | #ec representative

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What is the result of not appointing an Authorized Representative?

Authorized Representative' means any natural or legal person based in the Union who has been given an authorized written order from the manufacturer located outside the Union acting on behalf of the manufacturer in regards to specific tasks with regards to the manufacturer's ob