Todd has over 20 years experience in a combination of International Regulatory Affairs and Domestic Quality Engineering Management disciplines. Todd has the expertise and determination to partner with Medical Device Manufacturers to increase sales and revenue by opening up new international markets by successfully completing International Regulatory Affairs Projects for various European and non-European countries world-wide. International Regulatory projects that involve an expertise in working with Medical Device Directive (MDD) 93/42/ECC, EU Harmonized Standards, Essential Requirements, various Authorized Representatives and Notified Bodies, U.S. State Department, various Secretary of State Offices, Consulate Generals and Embassies, U.S. Department of Treasury, Office of Foreign Assets Control (OFAC), U.S. Export Administration and Bureau of Industry and Security (BIS), ISO 13483, FDA CFR 820 as well as a variety of other other CFRs, and many International Medical Device Regulations.
- 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)