Instrument Repair Services
Thirty-five years of experience in Regulatory (FDA) Submissions, FDA and ISO Quality Systems for the Medical Device and IVD industry. Additional experience with Quality Assurance, Manufacturing, Clinical Affairs, Medical Services, Customer Services and Instrument Repair Services.
Titles Held: Vice President of Quality Assurance/Regulatory Affairs; Vice President of Clinical, Quality and Regulatory Affairs; Director of QC/QA
- Clearance and Approval of over thirty-five 510(k)’s, PMAs and BLAs
- Managed three IVD corporations to ISO 9001 and 13485 Certifications
- Developed and Commercialized 8 lVD’s (R&D)
- CE Marking, Canadian Product Registrations, experience working in Germany and Japan
- Extensive knowledge of In-Vitro Diagnostics, all classes including Biologics