Team

Haim Sibony CEO, QA/RA Advisor & Lead Auditor

Haim is a Senior Consultant with vast experience in Regulatory Affairs and Quality Assurance. Haim is an ISO Certified Quality Manager (ICQM) and BSI-qualified Lead Auditor. Haim is a professional in ISO 13485 & ISO 14971 and a skilled Internal and External Auditor. As Quality & Production Manager in M.M.A.Tech Ltd., Haim managed the development of products in the field of orthopedic joint replacement and biomaterials.

Haim has also led large-scale projects as Quality Assurance Manager in Noris Medical and as Design Engineer of C.T. & Nuclear Medicine in Elscint Ltd.

Haim holds a B.Sc. in Electrical Engineering of Electronics & Computers from the Technion – Israel Institute of Technology (I.I.T.) and certification in Software Engineering from the College of Management.

Simha Sibony Regulatory Affairs Expert Consultant

Simha has over 25 years of experience in the fields of Regulatory Affairs and Quality Assurance of medical devices and biomaterials and 5 years of Material Engineering and R&D expertise in the Air Defense & Aviation industry.  Simha co-founded M.M.A.Tech Ltd., a start-up company that led the development of MP-1™ – a wear-free polyimide biomaterial for implants and medical devices.

Simha has also served as Vice President for a number of leading medical device and biotechnology companies such as Noris Medical, Hanita Lenses, and Commonsense. Simha provided Regulatory & QA services as an expert consultant to  Emergo.

Simha holds a B.Sc. in Chemical Engineering, an M.Sc. in Biomedical Engineering, and a Quality Engineer certification, all from the Technion – Israel Institute of Technology (I.I.T.).

Alex Shvartsberg System Engineer & Program Management, Regulatory Compliance, R&D Specialist Consultant

Alex has a proven track record of medical product development and helping clients bring medical devices to market. He is experienced in directing R&D programs leading to multiple patent filings for medical devices and regulatory approvals.

Alex holds a B.Sc. in Mechanical Engineering and an M.Sc. in Management Science from the University of Waterloo in Canada.

Alex has worked on many types of medical device product development projects, ranging from implants and disposables to highly complicated neurosurgical and general surgery robotic systems, Neurosurgical Brain Navigation systems, intro-operative MRI systems, patient handling devices, and therapeutic ultrasound systems.

Alex successfully led the regulatory clearance and the transfer to manufacturing of over 30 Class I&II (510K) and Class III (PMA) medical devices and has extensive hands-on experience with materials’ biocompatibility validation and implants’ sterilization validation.

Melaniya Shalmiev Licensed Dentist, Regulatory & QA Assistant

Melaniya is a licensed dentist with 10 years of experience, having acquired her Doctor of Dental Medicine (D.M.D) in Ukraine.        Melaniya also has a B.A. in Sociology and Anthropology from the University of Haifa.

Melaniya holds a Software testing QA certification from John Bryce College and is an experienced Quality Inspector, having worked at Flextronics and RH Production.

Roy MattarBusiness Developer & Regulatory Affairs Advisor

Roy is experienced in drafting and editing Clinical Evaluation Reports in accordance with MEDDEV 2.7/1 Rev. 4 and Medical Device Regulation 2017/745 Technical Documentation & ER compliance (incl. gap analysis & transitions).

Roy holds a Bachelor of Laws (LL.B.) from Tel-Aviv University in Israel and certification from Bocconi University School of Economics & Management in Italy.

Roy has gained his legal experience in prominent law firm Gornitzky & Co., working closely with a wide range of organizations, concerns, banks, government companies, and leading private companies, drafting court and company documents & agreements, and preparing legal opinions.

Roy has also served as Data Analyst in the “Omek” center for policy and legislation, assisting Knesset members in the conduct of national and international legal research for the drafting of Bills, and as Research Assistant in Constitutional & International Law for Prof. Aeyal Gross in Tel-Aviv University.

Naor Sibony Software Engineer & Computer Systems Validator

Naor is an accomplished Software Engineer and Computer System Validation (CSV) expert, specialized also in Data Security protection and Websites Management.

Naor holds a B.Sc in Computer Science from Bar-Ilan University and has gained considerable professional experience in the High-Tech industry working for many established tech companies such as CodeOasis and Kaltura. He is proficient in a wide range of programming languages, techniques, frameworks, and platforms.