Manage Change and Stay Safe
Updated medical device files are required to maintain legal access to most regulatory regions in the world, including the EU and the US. ISO 13485 and 14971 set requirements for risk management and control of design and development changes. An example of a typical change would be the introduction of new raw materials and processing chemicals, including suppliers of these. A change in manufacturing processes, including at contract manufacturers, should also be controlled. One important aspect of change control is evaluating the biological safety and performance impact on products when changes are made to product specifications or manufacturing processes. SAXOCON provides you with everything you need to evaluate the impact of design and manufacturing changes for compliance with regulatory safety requirements, including:
- Assessing the impact on existing biological evaluation in accordance with ISO 10993-1
- A toxicological risk assessment of new or changed levels of substances
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
- Extensiveexperience in state-of-the-art safety evaluations according to international standards and regional regulatory guidelines
- Safety evaluations based on non-disclosed information obtained from our worldwide network of material suppliers
- Smart, cost-effective test strategies that bring your products to market in a timely manner
SAXOCON compiles a toxicological statement that includes all required documentation supporting your Quality Management System. This can include an update of your Biological Evaluation Report and/or Biological Evaluation Plan if further information gathering or generation is necessary.
Reusable medical devices
AAMI TIR12 compliant cleaning procedures.
CE MArk certificate
Certify your products for sale in the EU.
Properly evaluate your materials.
PMT analysis for ISO 10993-19 compliance.