Sheena Bond is a scientist working as a Medical Device Auditor and previously the Certification Project Manager. She gained expertise in CE marking (European Directives), Canadian Medical Device Regulation and MDSAP (Medical Device Single Audit Program) working with both the French and German Certification Bodies. Sheena is a Certified Lead Auditor, and a Design Dossier Reviewer for high-risk In Vitro Diagnostic devices. Sheena has also worked in industry with leaders in the medical device and diagnostics arena. With more than 20 years of experience in the medical device industry, Sheena utilizes her technical and regulatory expertise to assist medical device manufacturers in implementing regulatory requirements and ensuring their Quality Management System ( QMS) compliance.
- 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)