21 CFR & ISO 13485 Integrated Quality Management System and MDSAP Integration with ISO 13485 Requirements

21 CFR & ISO 13485 Integrated Quality Management System and MDSAP Integration with ISO 13485 Requirements

ISO 13485 + MDSAP

In the framework of the Medical Device Single Audit Program (MDSAP), organizations’ Quality Management System can be audited for potentially five different Medical Device markets. For companies selling or looking to expand their sales to one or to all of the countries involved in the MDSAP program (Australia, Brazil, Canada, USA, Japan), it is important to know that at a minimum, the requirements of ISO 13485 will be included in the auditing criteria along with only the applicable regulations of the authorities the company is concerned with.

These new rules and revisions stretch throughout the QMS, especially for those managing large networks of suppliers and vendors. Document management, change control, supply chain, product lifecycle, as well as device usability and post market surveillance requirements will all be affected.

In essence, MDSAP enables medical device manufacturers to contract with an authorized third party auditing organization to conduct a single audit which satisfies all regulatory authorities in a given market. Besides FDA, other authorities participating in the program include those in Australia, Brazil, Canada, and Japan.

At Maven we have experienced experts who can guide you through your MDSAP certifications, train you on the specific requirements and integrate your QMS with the MDSAP requirements for compliance.

C.ISO 13485 + 21CFR

Title 21 CFR 820 is the current quality system for medical devices used by the FDA. The FDA enforces this title currently, but they will move from 21 CFR 820 to ISO 13485:2016 which will simplify the QMS of companies seeking FDA approval for their medical devices and makes it easier for international trade.

21 CFR 820 is applicable to manufacturers of finished medical devices sold in the United States, including imported products. Only parts of the requirement may apply, depending on the class.

Although similarities exist between FDA QSR and ISO 13485 requirements, US medical device market applicants must ensure compliance specifically to 21 CFR Part 820 in order to register their devices for sale, regardless of whether they have already obtained ISO 13485 certification.

We can help you in your QMS transformation & compliance to 21CFR requirements


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