A CE Mark certificate is needed to market a medical device in the EU. This certificate verifies that the product is safe and performs as intended. The ISO 10993-1standard prescribes a process for designing, testing, and documenting the biological safety of a medical device product.
Both implanted medical devices and medical devices that come into contact with circulating blood must undergo a physicochemical, morphological, and topographical (PMT) characterisation to document compliance with regulatory requirements, including: shape and form, morphology, topography, surface chemistry, etc.
SAXOCON provides you with everything you need to document compliance with regulatory requirements, including:
- Measurements of physico-chemical, morphological, and topographical properties according to ISO 10993-19:2020
- Documentation and presentation of results
- An overall risk assessment of the device
Why choose us?
SAXOCON analytical services for nanomaterials give you access to:
- Extensive expertise in the measurement and characterisation of materials and surfaces
- A multidisciplinary team of highly skilled scientists and experts
- High-level experience in state-of-the-art toxicological evaluations according to international standards
SAXOCON generates and compiles all the physical characterisation data needed to support the biological evaluation of your product.
Reusable medical devices
AAMI TIR12 compliant cleaning procedures.
CE MArk certificate
Certify your products for sale in the EU.
Properly evaluate your materials.
Stay ISO 13485 and 14971 compliant.