Eli Werner Email & Phone Number

• Over 34 years in field of medical devices industry CT, ULS, MRI & NM. Filling various leading and management roles at System engineering, Service, Manufacturing, Quality Assurance & Regulatory Affairs.• Over 10 years of experience in area of safety & regulatory affairs for medical devices. • Proven experience in FDA 510(k)’s submissions for NM & CT medical devices.• Proven experience in preparation & assessment of Technical Files per MDD European Directives & Canadian Medical Device Requirements • Maintenance/creation of compliance files needed for registration in health authorities world-wide countries especially in USA Europe Canada Japan China Korea, South America & Israel. • Demonstrated experience in interfacing with regulatory agencies (FDA, &EU) and standards bodies such as, IEC, ETL & CSA• Deep Knowledge of Quality Management Systems (ISO 9000, ISO 13485, QSR, MDD & CMDR)• Experience in audits of EU notified bodies & FDA.• Active assistance in Risk Analysis/Management process per ISO 14971.• Specific knowledge & experience in wide range of EN/IEC60601 family standards. Knowledge and experience in IEC60601-1 safety standards of ed 2 & ed 3 collateral and particulars standards .Experience in working with local CB laboratories and NRTL such as CSA INTERTEK & TUV.