Safe Stents and Implants
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
SAXOCON compiles all necessary documentation for the approval of your product in a Biological Evaluation Report.
Test and document device compatibility.
breathing gas pathways
Breathing gas pathway compliance.
Safe in-vitro diagnostics
(EU) 2017/746 (IVDR) Annex I compliance.