Hieu is a consulting professional with 25 years of medical device experience in strategic planning, product development pipeline, new product commercial releases, design control, and program management. Hieu has a proven track record of successful global commercial launches of class II and III products and sometimes multiple products at the same time. Hieu has worked in start-ups and global medical device and pharmaceutical companies. With Hieu’s unique broad spectrum experience, Hieu can help you generate a strategic plan, align it with the product development pipeline, and execute the projects to product commercial launches.
- 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)