Medical device manufacturers need to screen the materials used in their products. Proper biosafety and sourcing require having full transparency about the physical and chemical information associated with the materials throughout the supply chain. Knowing what is in the materials you use helps mitigate risk, reduces unexpected findings, and keeps regulators happy.
To operate in the EU, medical device manufacturers must ensure the quality and safety of the materials used in their products before they can bring them to market. Early and robust materials selection helps meet regulatory requirements, mitigate risk, and get your products to market quickly.
SAXOCON has several services to help you understand your materials and get compliant with all relevant regulations:
Materials Screening
Primary Packaging Safety
Safe Drug-delivery Devices
Surface Characterisation
Safe Food Contact Materials