Matthew is an experienced Quality Systems Manager with over 18 years of expertise in Regulatory, Manufacturing, Design, and of course, Quality. Matt takes the time to focus on a company’s agreed upon goal and then takes the proper course of action to achieve the desired result. He believes in developing systems by integrating the regulatory requirements in the planning process, which in turn streamlines the work for your company.
- 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)