MRM | Medical Risk Management

We supports you in your efforts to comply regulatory requirements of the EU, Canada and the US; and to bring your medical device on the market.

This can be

  • MDR + Article 15 (PRRC – ‘Person Responsible for Regulatory Compliance’)
  • IVDR + Article 15 (PRRC – ‘Person Responsible for Regulatory Compliance’)
  • 510(k)
  • Clinical evaluation + PMCF
  • PMS / Vigilance processes
  • AU Authorized Representative + FSC (Free Sales Certificate)
  • Quality Management System (ISO 13485)

Please contact us for more information.

FullServiceModel MRM

 

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  • BREXIT impact
    How medical devices are currently regulated All medical devices are subject to EU legislation, which requires a manufacturer to place a CE mark on their product to attest compliance to applicable standards. Medical devices are regulated under Directive 90/385/EEC on active implantable medical devices (AIMDD), Directive 93/42/EEC on medical devices (MDD) and Directive 98/79/EC on in vitro diagnostic medical devices (IVDD). These directives are transposed into UK law as the Medical Devices Regulations 2002. Manufacturers of low-risk devices (Class I medical devices) can self-declare conformity to the legislation before affixing the CE mark. Higher-risk devices (such as Class IIa, IIb…

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