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Our quality and regulatory experts can work alongside you throughout your development process of medical devices, combination devices and in vitro diagnostics (IVD). 

We can work within your quality system, or our ISO 13485:2016 certified quality system, assess your business and design needs and then create or guide compilation of documentation packages compliant to:

  • ISO 13485:2016

  • 21CFR 820

  • Medical Device Single Audit Programme (MDSAP)

  • Medical Device Regulation (MDR)

  • In vitro diagnostics Regulation (IVDR)

  • IEC 62304

  • ISO 14971

  • IEC 60601

Incorporating quality throughout your design process enables your R&D teams to stay focussed on new development and ensures timely and cost-effective creation of critical documentation and control of development processes reducing time to market.

In addition, we can offer Design History File remediation for existing designs, creation of design documentation for medicinal products, veterinary products, consumer goods and beauty and consumer healthcare products.

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