Planned and executed 510(k) strategy for AAMI Level 4 Surgical Modular Toga (Gown and Hood). Obtained K200977 clearance. Drafted Pre-Submission for planned 510k for Level 4 Toga with battery powered HEPA Air shoulder mounted system to prepared for 510(k) submission. Program managing development team and Contract Manufacturer to perform all testing and perform all validation to ensure successful 510(k) submission. Developed entire QMS for specification developer and acting as Quality Manager/Person Responsible for Regulatory Compliance for managing and running QMS in both US and EU.