The Laboratory Testing Division is uniquely positioned as both regulatory and technical experts for medical device testing. Our comprehensive platform of services supports medical device manufacturers with testing from development through lifecycle management to ensure product safety throughout. We act as a partner to our customers, providing guidance on submissions to global regulatory bodies based on the vast diversity of products we’ve tested.
Technical & Regulatory Expertise
Our medical device testing experts serve on international standards committees as active participants and leaders, which enables us to be proactive in our approach based on how the regulatory environment is shifting. Our chemistry staff works to ensure our chemical data has complete chemical identification so that our toxicologists can use this data to write a comprehensive toxicological risk assessment. Without complete chemical characterization, it is unlikely that the risk assessment would be favorable, as unidentified chemicals or “unknowns” must be classified as carcinogenic/genotoxic. It may take as little as 1.5 µg/device of an unknown to have an unfavorable risk assessment.
In addition, we track regulatory trends through sponsor or regulatory inquiries we receive, and will adapt our strategy based on trends analyzed by our regulatory and technical experts. These trends, combined with our transparency with regulatory agencies, has aided in our approach to reprocessing cleaning and disinfection efficacy and validation studies.
Above all, we stand behind our work – from test plans through clearance – responding to questions or other regulatory requests as part of the submission process.