Alan is an experienced Senior Project Engineer with expertise in all areas related to bringing new single-use medical devices to market and into high volume production. Beyond the broad view of project management, Alan can assist with the details such as identifying specifications of mechanical components, analysis of technical drawings, and development of a system interface that conforms to standards, customer requirements, and system architecture requirements.
- 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)