As a sterile medical device manufacturer, you must ensure that your product meets the relevant regulatory requirements before being placed to the market
Bringing compliant products efficiently and safely to the market might be a challenging process for medical devices manufacturers. We offer standard and dedicated product review services providing you with efficient pathways to bring your device to market.
What is a sterile medical device?
A sterile medical device is a device that must be free from viable bacteria or other microorganisms and their spores. Sterile medical device requirements are defined by national or regional standards and regulations, which detail the level of sterility assurance. Sterilization of a medical device may include exposure to ethylene oxide, gamma irradiation, steam, dry heat, or chemical sterilization under defined conditions, and any necessary post-treatment required for the removal of by-products.