JR has more than 20 years experience in Quality Systems and Manufacturing Operations. She has experience with medical devices and pharmaceutical products offering clients a broad knowledge base when it comes to current Good Manufacturing and Laboratory Practices and quality system standards. Her background includes implementation of Quality Management Systems, development of Quality Documents, internal and supplier audits, nonconformance systems, and training. JR is a detail-oriented professional who believes in adding value to whatever project she is given.
- 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)