Ilan Sharon Email & Phone Number

Self employed Medical devices Consultant Current Among others, some sample activities: • Medical Imaging Devices – QA and regulatory management: including DHF, internal and external audits, 510(K) submissions and QSR activities, EEC (MDD 93/42/EEC) Quality and regulatory activities, CMDCAS license submissions/ activities.....• Life supporting devices – Comply with QSR: including Design Control requirements, DHF, 510(k) submissions, LTFs, EEC (MDD 93/42/EEC) Quality and regulatory… Show more Self employed Medical devices Consultant Current Among others, some sample activities: • Medical Imaging Devices – QA and regulatory management: including DHF, internal and external audits, 510(K) submissions and QSR activities, EEC (MDD 93/42/EEC) Quality and regulatory activities, CMDCAS license submissions/ activities.....• Life supporting devices – Comply with QSR: including Design Control requirements, DHF, 510(k) submissions, LTFs, EEC (MDD 93/42/EEC) Quality and regulatory activities, CMDCAS license submissions/ activities, Internal Audits and managing suppliers Audits by large US distributors.... • In-vitro products - Upgrade and maintenance of QA system and product QC per IVD directive (98/79/EC) and FDA QSR requirements, CMDCAS submissions/ activities.....• Dental devices – Including QSR preparation (comply with 21 CFR 820 requirements), DHF, Technical Files preparation , MDD (93/42/EEC) requirements and CMDCAS license submissions.... • Aesthetics Medical Devices - Including QSR preparation (comply with 21 CFR 820 requirements), DHF, QS certification and Technical Files preparation per MDD (93/42/EC) and CMDCAS license submissions..... Show less

• Quality and Operations VP: Operations and Quality activities of medical design and manufacturing firms, including: upgrade, implementation and maintenance of QS, QC and regulatory affairs.• Consulting, preparation, submissions and listing medical devices (FDA, CMDCAS, CE …)

Founding and managing a new Medical Device Department within the SII• Activities: Consulting and constructing FDA submissions and Technical Files (EEC MDD 93/42/EEC). MDD training and organizing formal SII training courses for QA personnel. Coaching medical device manufacturers for preparations to FDA, Notified Bodies (NB) audits. Participating FDA and NB audits. Coaching MD manufacturers for compliance with Medical Devices standards. • Active in Medical Device Forums in SII and Israeli… Show more Founding and managing a new Medical Device Department within the SII• Activities: Consulting and constructing FDA submissions and Technical Files (EEC MDD 93/42/EEC). MDD training and organizing formal SII training courses for QA personnel. Coaching medical device manufacturers for preparations to FDA, Notified Bodies (NB) audits. Participating FDA and NB audits. Coaching MD manufacturers for compliance with Medical Devices standards. • Active in Medical Device Forums in SII and Israeli Ministry of Health. Show less

Leading concern of innovative Medical Imaging and Diagnostics (CT, MRI, Nuclear Medicine and Ultra-sound equipment).• Activities: R&D engineer and later R&D Project leader, Manufacturing Manager, Service and Customer Support manager and QA and Regulatory Affairs (reporting to QA VP).