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Safe Stents and Implants

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A CE Mark certificate is needed in order to market an implanted medical device in the EU. This certificate verifies that the product is safe and performs as intended. The ISO 10993-1 standard prescribes a process for evaluating and testing the biological safety of a medical device product, including the physicochemical, morphological, and topographical characterisation of materials.

SAXOCON provides you with everything you need to plan, test, and document compliance with regulatory requirements, including:

  • A Biological Evaluation Plan to describe and justify your test strategy
  • The robust selection of construction materials
  • Physicochemical, morphological and topographical tests according to methods and principles in ISO/TS 10993-19
  • Choosing appropriate laboratories, reviewing protocols, and monitoring biological tests according to the requirements in the ISO 10993-series
  • Assistance with scientific advisory meetings with regulatory bodies
  • 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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