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MEDICAL DEVICE & IVD COMPLIANCE

We provide regulatory support to comply with the below directives and regulations: 

  • EU: Directive 93/42/EC and MDR 2017/745 on medical devices 
  • EU: Directive 98/79/EC and IVDR 2017/746 on in vitro diagnostic medical devices
  • USA: FDA 21 CFR parts: 820, 809, 822 and part 349 over the counter drugs
  • Canada: Canadian Medical Devices Regulation SOR 98-282 and NNHPR, SOR/2003-196 (Natural Health Products)
  • Australia: TGA ARGMD (Medical Devices)
  • Singapore: HSA GN-01 (Medical Devices)
  • Brazil: INMETRO and ANVISA's regulatory requirements

Further information regarding services, expertise and how our experience can support your business?

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