Rob has more than 20 years experience and deep knowledge of the software development lifecycle with a focus on risk assessment, requirements development, validation activities, and configuration management. Rob specializes in validating non-device software applications including quality management systems (PLM, LMS), machine control software, analytical instrumentation software, business integration systems (middleware), and mobile applications. Rob has a proven track record of leading successful system implementations. Rob’s knowledge of best practices, his writing skills, and use of templates enable implementation of compliant systems in a least burdensome, efficient manner
- 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)