Gadi Shtepel brings with him over 35 years of experience in the fields of Quality Assurance and Regulatory Affairs- the last 15 years in the Medical Device industry.
For the last 3 years Gadi was the Head of Quality Systems and Director Regulatory Affairs for Medinol Ltd. a leader in area of Cardiovascular Stent Systems. Gadi maintained a Quality System to the requirements of ISO 13485: 2003 and the FDA-QSR and also managed the regulatory CE Mark submissions (per MDD Annex II) and FDA-PMA maintenance.
Previously Gadi spent 2 years at BioControl Medical an Active Implantable Medical Device Start-up company where he served as the Director of Quality Assurance. While at BioControl he implemented and registered the Quality System to the requirements of ISO 9001: 2000, ISO 13485: 2003 and achieved a CE Marked for an implanted stimulator per the AIMD directive.
For almost 10 years Gadi served as the Head of Quality Services in Elan Medical Technologies, a subsidiary of Elan Corp. PLC a multi national company (USA, Ireland and Israel), developing and pilot manufacturing disposable medical devices for parenteral drug delivery (Drug – Device combination). Gadi oversaw the implementation of the Quality System and its Certification to the applicable requirements and CE Marking (Medical Device Directive Annex II), and FDA –QSR. In addition, he was responsible for all QA activities in the Design & Development cycle and GMP clean room manufacturing.
Gadi holds a B.Sc. in Aeronautical Engineering from the Techinon- The Israeli Institute of Technology