These assays characterize raw materials and components of medical devices, which helps achieve biocompatibility and reproducibility in manufacturing.
Efficacy verifies that products perform according to the intended function. Non-clinical studies are used to select prototypes and provide an understanding of device performance.
Safety evaluation studies in vivo and in vitro, are conducted on a variety of biomaterials, medical devices and related products to identify the presence of toxins or any potentially harmful effects.
Clinical trials in compliance with ISO 14155 standards are conducted through Biomatech, NAMSA’s European Laboratory. Investigations assess device performance, possible secondary effects and risk acceptability.
Comprehensive sterility assurance programs include custom protocols backed with complete documentation, which fulfills all necessary regulatory requirements. Capabilities include all areas of microbiological quality assurance.
The path to launching a medical device into the market can be long and complex. You need a trusted advisor who can simplify and shorten the path for you at any time.
