Abstract
AbstractApplying Good Laboratory Practice (GLP) regulations to studies of medical devices and combination products (drug/device products) presents some unique challenges. The complexity of medical devices – which may be internal, external, or composed of many intricate parts including software, hardware, or drugs to perform their intended task – requires interpretation of the regulations. Further, the dynamics of the conduct of non‐clinical laboratory studies for medical devices can be quite complex often involving a team of scientists, engineers, computer specialists, technicians, veterinarians, physicians, pathologists and equipment from both the test facility and sponsor. This article highlights areas of the GLP regulations and provides information and suggestions for GLP compliance for medical device studies. Copyright © 2002 John Wiley & Sons, Ltd.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
