Safe In-Vitro Diagnostics

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A CE Mark certificate is needed in order to market an in-vitro diagnostic medical device in the EU. This certificate verifies that the product is safe and performs as intended. Regulation (EU) 2017/746(IVDR) Annex I prescribes general safety and performance requirements for designing and verifying an in-vitro diagnostic medical device product. SAXOCON provides you with everything you need to plan, test, and document compliance with regulatory requirements, including:

  • The selection, screening, and characterisation of construction materials and reagents in order assure compatibility with the bodily fluid, cell or tissue samples intended to be tested
  • Evaluating compliance with Regulation (EU) 1272/2008 governing the Classification and Labelling of Hazardous Substances
  • The selection of appropriate laboratories, review of protocols, and monitoring of required tests
  • A toxicological risk assessment of results

Why choose us?

SAXOCON services for medical device manufacturers give you access to:

  • A multidisciplinary team of highly skilled toxicologists, material scientists, and supply chain professionals
  • Extensive experience with state-of-the-art safety evaluations according to international standards and regional regulatory guidelines
  • Safety evaluations based on proprietary information obtained from our worldwide network of materials suppliers
  • Smart, cost-effective test strategies that bring your products to market in a timely manner

Delivery

SAXOCON compiles all necessary documentation for the approval of your product in a Biological Evaluation Report.

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