Ilan Goldberg Email & Phone Number

Haifa District, Israel

Ramat Hasharon, Israel, Il

Tirat Carmel, Tirat Carmel, Il

Formatk is a leading provider of energy-baseddevices for the medical aesthetic industry

Ramat Hasharon, Israel, Il

Physio-Logic offers fully integrated (one-stop-shop) services to medical device and bio-pharma companies and specializes in complex development programs that require highly innovative regulatory and clinical strategies. We are the experts in implementing and conducting successful regulatory activities, clinical trials and quality assurance programs. Physio-Logic is an international company staffed by full time senior-level professionals who provide unparalleled experience and expertise honed by years in the industry. We know how to get each job done with great efficiency and unflagging tenacity. We investigate all options and bring each project to fruition in a timely and budget-conscious manner. Physio-Logic offers a fully comprehensive network of experts, all within a single organization. Hailing from multiple, yet complementary disciplines, our team, working in tandem with yours, is able to evaluate each project from many diverse points of view, creating collaborative and inspired outcomes.

Haifa, Il

We are proud to present you with cutting edge technology in soft laser therapy: clinical soft laser power - in a light, portable, rechargeable and user friendly medical device, for the rapid, non-invasive and efficient treatment of pain, wounds, burns, sports injuries, inflammation, acne, and skin rejuvenation. It is the first portable soft laser device in the world with the healing power equal to that of a full-sized, stationary, expensive soft-laser machines used only in hospitals and prestigious care facilities.

MedicNRG is a leading company in the global Endo technology field, and a major manufacturer of Electronic Apex Locators (EAL) . We are unique in our the capability to exactly define a need, “know how” in dental and technological fields and an advanced marketing perception. We aim to integrate design and user friendly interfaces as essential components of our devices’ identities, creating excellent tools in hands of dentists and advancing healthy dentistry.

As the leading global standards, training and Certification Company and Medical Device Notified Body, BSI helps over 70,000 clients worldwide to improve their businesses. We support businesses to embed the habits of excellence so they perform better, achieve sustainable growth, ensure their systems and products meet regulatory requirements, bring new medical innovations in a timely manner to global markets and in doing so, we touch the lives of many across the globe.ilan.goldberg@bsigroup.com

SpiralTech and the human body go hand-in-hand with each other. Patented implants are made of biological material that the body recognizes and facilitates a recovery like never before.My assignments:- Creating a Global Regulatory Affairs Strategy- Set up of QMS per ISO 13485:2012+CMDCAS- Implement the QMS at SpiralTech USA in Chicago, on January 2015- Prepare SpiralTech USA for ISO 13485+CMDCAS audit in Chicago. The audit by SGS was finished with zero non-conformance.- Submit Technical File for CE certification- Creating Technical File for FDA 510k submission

NovellusDx is developing a cell-based, in-vitro assay that enables monitoring the activity level of the signaling pathways in a patient's tumor. NovellusDx is able to monitor the activity of the signaling pathways after drugs are administered in-vitro, allowing NovellusDx to asses the response of a specific tumor to an array of drugs.

o FDA Quality System Regulation 21 CFR 820 (QSR)o Medical Device Directiveo Design Process/Design Planningo Set up of Quality Management Systemo ISO13485 Medical Device Quality Management Systemo ISO14971o Technical File for CE, FDAo FDA inspections,o ISO 13485 surveillance auditso Control of Clean-room class X according to ISO-14644-Xo Control of Bioburden of Clean-room and surgical instrumentso Control of ETO and Gama Rays Radiation sterilizationo Internal/Supplier audits o Review current technical product files for complianceo Guidance on product design to R&D redevelopment teamsThe FNA - EUS product:Endoscopic Ultrasound (EUS) combines endoscopy and ultrasound in order to obtain images and information about the digestive tract and the surrounding tissue and organs. Endoscopy refers to the procedure of inserting a long flexible tube via the mouth or the rectum to visualize the digestive tract (for further information, please visit the Colonoscopy and Flexible Sigmoidoscopy articles), whereas ultrasound uses high-frequency sound waves to produce images of the organs and structures inside the body such as ovaries, uterus, liver, gallbladder, pancreas, or aorta.

- Creating a Global Regulatory Affairs Strategy- Set up of QMS per ISO 13485- Implement the QMS at Mirell B.V in Amsterdam, Netherlands- Prepare Mirell BV for ISO 13485 audit by SGS, in Amsterdam, Netherlands- Submit Technical File for CE certification- Submit application for TFDA in Taiwan- Submit application to Ministry of Health and Family Welfare (MHFW)-Government of India- Registering with AMAR, the Israeli Ministry of Health’s medical device regulation unit- Creating Technical File for FDA 510k submission- Prepare for application to National Health Surveillance Agency - ANVISA BRAZIL

Kibbutz Gaaton, Il

•Implementation of effective quality management system•Act as designated management representative for the quality system.•Annually audited by our clients: Johnson & Johnson and Stryker. •Manufacturing Process Control•Versed with Implants for Arthroscopic surgery. •Support verification and validation testing, IQ/OQ/PQ.•Control of Clean-room class 8 according to ISO-14644-X•Control of Bioburden of Clean-room and surgical instruments •Control of ETO and Gama Rays Radiation sterilization•QC of disposable sterile products •Lead Auditor Internal/Suppliers/Sub Contractors audits •Initiated a project for reduction of non conformance in production line, that resulted in cost reduction of 15% of obsolete parts/assemblies, within 9 months.•CAPA, MRB, Non-conformance Analysis, Customer Complaint. •Suppliers qualification and classification•Training of production workers to meet ISO 13485, QSR, MDD, CMDCAS requirements

Yokne'Am Ilit, Tsafon, Il

Carlsbad, Ca, Us

Yakum, Il

Industrial Engineering And Management (Ie&M)

Diploma, Quality Assurance & Regulations - Medical Devices

Business Administration

Practical Engineer, Engineering/Industrial Management