August 19, 2019 | By: Alpa Patel and Emily Mitzel
Validating cleaning instructions for a tray of reusable orthopedic devices is an important milestone on the path to obtaining FDA clearance for those devices.
Although the process of validation can seem daunting at first, medical device manufacturers seeking to successfully navigate this process can do so confidently and efficiently if they are armed with knowledge, education, and guidance.
Download this white paper to get detailed information on successful medical-device cleaning validations.
Senior Scientist, RM (NCRM)
Alpa Patel is a certified microbiologist and has been part of the medical device industry for 18 years specializing in cleaning/disinfection and sterilization of reusable medical devices, endoscopes and validation of tissue disinfection or sterilization processes. Her current role as a principal scientist at Nelson, involves overseeing test method validations for reprocessing, writing standard test protocols (STP) and standard operating procedures (SOP) for reprocessing and other internal and globally related documents, providing technical consulting for the Reprocessing sections at Nelson Laboratories in Salt Lake City and globally.
MS Reusable Medical Devices Expert
Emily Mitzel is an Expert Advisor and Senior Scientist at Nelson Labs. Her expertise includes reusable device reprocessing validations, newly manufactured device validations, sterilization, and microbiology testing.
