Biological Safety of Device
Biological safety of a medical device is an essential requirement for the market approval. New devices or pre-existing devices must undergo biological evaluation within the risk management process.
Toxicological Risk Assessment
The first step in biological evaluation is the gathering of physical and chemical information on the medical device or component.
Gap Assessment
Your device has undergone a design change, manufacturing process change, location change, material change, intended use change, or specific requests by regulatory bodies!
Consultancy for Material Safety
Is your material REACH & RoHS compliant? Does it meet MDR’s substances requirement?
Failed Biocompatibility test
Testing phase of your medical device is full of excitement and biocompatibility testing can come with surprises.
Particulate testing of medical devices
Presence of particulate matter on medical devices can occur due to manufacturing environment/processes or due to a device design related issue.