Linda is an experienced Quality System Specialist in the medical device industry. She provides companies with expertise in developing, implementing, and maintaining quality assurance systems for a variety of devices and levels of company sophistication. Her experience allows her to support easier maintenance and greater compliance with regulatory requirements. Linda is a proven problem-solver who works collaboratively with management and cross-functional teams.
- 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)