Doug is a Microbiologist with over 30 years of experience in the medical device and biopharmaceutical industries. He has extensive experience in ethylene oxide, radiation (gamma and e-beam), and liquid chemical sterilization validation, reprocessing of devices, microbiology laboratory testing and management, controlled environment monitoring, biocompatibility, audit of contract laboratories and sterilization facilities, and support of regulatory submissions. He is also an active member on several AAMI sterilization standards committees.
- Final FDA guidance explains how the agency evaluates benefit and risk issues in Investigational Device Exemptions (IDE) for medical devices that require clinical trials in order to be registered.
- Final US FDA Guidance on Post-market Cybersecurity Risk Management
- ISO 13485:3026
- Due Diligence and QMS assistance
- Reasons Your 510(k) Submission Will Be Rejected (And How To Avoid Them)