Safely Manage Change
Updated medical device files are required to maintain legal market access in most regulatory regions, including the EU and the US. ISO 13485 and 14971 set requirements for risk management and the control of design and development changes. A typical change requiring updated documentation would be the introduction of new raw materials or processing chemicals or when switching to a new raw materials supplier. Another example is changes in the manufacturing processes, including those at contract manufacturers. Additionally, change control requires evaluating what impact product specification or manufacturing process changes will have on a product’s biological safety and performance.
SAXOCON provides you with everything you need to evaluate the impact of design and manufacturing changes on compliance with regulatory safety requirements, including:
- Assessing how such changes impact existing biological evaluations per 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
- Extensive experience with 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
Delivery
SAXOCON compiles a toxicological statement with all the required documentation to support your Quality Management System. This documentation includes, but is not limited to, updating your Biological Evaluation Report and/or Biological Evaluation Plan if further information gathering or generation is required.