QMS & Medical Device Certification

Medical Devices are highly regulated products & different countries have a different regulatory approach(for that we need different medical device certification) for market clearance & sale of medical devices. Medical device varies in size, ease of use, safety ranging from simple bandages, surgical instruments to implants & complex systems involving software. When a manufacturer decides to enter a new market, he has to consider not only the regulatory requirements of that particular market but also has to determine how those requirements apply to his product.

We Provide Following QMS & Medical Device Certification Services For Manufacturers:

US FDA 21 CFR Part 820 Quality system regulation

US FDA Part 820 covers the processes used in, & the facilities & controls used for the design, manufacture, packaging, labelling, storage, installation & servicing of medical devices.

21 CFR Part 210 & 211 Quality Assurance

21 CFR Part 210 deals with the Manufacturing, Processing, Packaging or  Holding of drugs, while CFR Part 211 deals with finished pharmaceuticals.

ISO 13485 Medical Device Certification Consultant

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices

ISO 15378 Quality Assurance

Quality assurance: ISO 15378 Primary packaging materials for medicinal products particular requirements for the application of ISO 9001:2008, with reference to GMP.

DMF File Submission Guideline

The manufacturer/supplier (DMF holder) files the DMF to provide information confidentially to US FDA. A DMF is neither approved nor rejected; it is reviewed by FDA when referenced by an applicant in a regulatory submission.

US FDA 510(k)

In the US, the USFDA regulates the sale of medical devices. There are different regulatory controls for devices of different classes. For class I devices & some 510(k) exempted devices, there is an establishment & registration & device listing.

CDSCO License & Sale Approval

The Medical device industry in India is regulated by the Central Drugs Standard Control Organization (CDSCO) under the regulatory provisions of the Drugs & Cosmetics Act 1940 & Rules 1945.

CE Marking

In order to market products in the European market, the products must have a CE mark which declares that a product meets the all relevant European Medical Device Directives.

Get Register QMS & Regulatory Certification For Your Medical Device

Our Other Services

Manufacturing Site Design and Conceptualization

Regulatory Compliances

Medical Device/Drug-Device Combination Product Design & Development

Medical Device Post Marketing Support

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