Marilyn has over 35 years of quality assurance experience in the medical device industry and additional expertise with the IVD Directive. She offers leadership and professional insight for companies during any point on their path to bringing their product to market. She has served as a Director of Quality Assurance at a vast array of medical device companies. Marilyn is a RABQSA Certified Lead Auditor with many more certifications and credentials under her belt.
- 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)