MEDICAL DEVICE LEGAL EXPERTISE
ProtomedLabs can provide expertise to attorneys and prosecutors when medical device manufacturers are faced with legal proceedings. Our engineers can provide expertise to review, analyze, and interpret test standards and guidelines in order to determine test requirements and adequate test methods to be used. Independent third party device performance testing can be conducted on test samples to determine whether or not devices comply with regulatory standards and guidelines. Literature search can be conducted using an internal Standard Operating Procedure to properly identify publications that can be used to substantiate acceptance criteria. All legal work is conducted under full protocol and optimum traceability requirements. A full set of documents and presentations can be prepared and delivered including test protocols, test reports including all reviewed materials, as well as referenced standards, guidelines and publications. This work is conducted using a fully documented process to comply with most stringent medical device directives.