Ilan Goldberg Email and Phone Number
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Currently retired.Over 35 years of extensive experience in the medical devices industry including managing quality and regulatory affairs departments in both well-established and start-up companies.In-depth experience with implementing MDSAP incl. Country Specific Requirements of Australia, Japan, Health Canada and EU MDR and UK new regulation on 2021.Successfully implemented EU MDR 2017/745 in 3 Medical Devices companies.Submit application to TFDA in Taiwan, Ministry of Health and Family Welfare (MHFW)-Government of India, AMAR the Israeli Ministry of Health’s medical device regulation unit, PMDA Japan, TGA Australia.Prepare SpiralTech USA for CE certification, ISO 13485+CMDCAS audit in Chicago. The audit by SGS was finished with zero non-conformance.Was hired by BSI, trained and practiced to be a Medical Devices assessor. Now days I'm an expert in Medical Devices Regulation 2017/745 MDR.In-depth experience with Combination Product (Pharmaceutical & Medical Device), IVDR and Medical Devices Class III with Animal Tissue.
Physio-Logic Ltd.
View- Website:
- physio-logic.co.il
- Employees:
- 35
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Sr. Qa And Ra Expert, Medical Devices Consultant - RetiredPhysio-Logic Ltd.Haifa District, Israel
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Sr. Qa/Ra Expert, Medical Devices Consultant - RetiredPhysio-Logic Ltd. Jul 2022 - PresentRamat Hasharon, Israel, Il
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Sr. Qa/Ra Expert, ConsultantFormatk Systems Ltd. May 2020 - Jul 2022Tirat Carmel, Tirat Carmel, IlFormatk is a leading provider of energy-baseddevices for the medical aesthetic industry -
Sr. Qa/Ra Expert Medical Devices Eu Mdr 2017/745Physio-Logic Ltd. May 2016 - May 2020Ramat Hasharon, Israel, IlPhysio-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.
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Global Qa/Ra ConsultantB-Cure Laser Jun 2014 - Oct 2017Haifa, IlWe 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. -
Quality Assurance And Regulatory Affairs ConsultantMedicnrg - Precise Endo Technology Dec 2014 - Jul 2017MedicNRG 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.
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Medical DevicesBsi Training Academy In Davy Avenue Knowlhill, Milton Keynes Mk5 8Pp, United Kingdom Sep 2014 - Sep 2016As 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
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Global Qa/Ra ConsultantSpiraltech Usa - Superior Dental Implants Feb 2014 - Jan 2016SpiralTech 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
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Qa And Operations ConsultantNovellusdx - Path To Cancer Care Dec 2013 - Dec 2014NovellusDx 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.
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Quality Assurance ConsultantFna Technologies Ltd. - Endoscopic Ultrasound Jan 2013 - Dec 2014o 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.
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Global Qa/Ra ConsultantMirell Oct 2013 - Jul 2014- 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
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Deputy Director, Quality AssuranceT.A.G. Medical Products Ltd. Oct 2010 - Dec 2012Kibbutz 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 -
Quality System ComplianceLumenis 2007 - Oct 2010Yokne'Am Ilit, Tsafon, Il -
Global Operations And Qa/Ra ManagerApplied Spectral Imaging Ltd. Dec 2004 - 2007Carlsbad, Ca, Us -
Operations And Qa/Ra ManagerEdge Medical Devices 2001 - 2004
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Vp Operations & QaCarestream Health 1996 - 2001
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Director, Global OperationsElron Electronic Industries Ltd. 1994 - 1996 -
Director, North Business UnitMatav-Cable Tv (Currently Hot) 1990 - 1994Yakum, Il -
Production Manager Ct/MriElscint Medical Imaging (Currently Philips Healthcare) 1973 - 1989
Ilan Goldberg Skills
Ilan Goldberg Education Details
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Technion - Israel Institute Of TechnologyIndustrial Engineering And Management (Ie&M) -
Ald CollegeQuality Assurance & Regulations - Medical Devices
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Management CollegeBusiness Administration
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Technion - Israel Institute Of TechnologyEngineering/Industrial Management
Frequently Asked Questions about Ilan Goldberg
What company does Ilan Goldberg work for?
Ilan Goldberg works for Physio-Logic Ltd.
What is Ilan Goldberg's role at the current company?
Ilan Goldberg's current role is Sr. QA and RA Expert, Medical Devices Consultant - Retired.
What is Ilan Goldberg's email address?
Ilan Goldberg's email address is cl****@****net.net
What is Ilan Goldberg's direct phone number?
Ilan Goldberg's direct phone number is +9725456*****
What schools did Ilan Goldberg attend?
Ilan Goldberg attended Technion - Israel Institute Of Technology, Ald College, Management College, Technion - Israel Institute Of Technology.
What are some of Ilan Goldberg's interests?
Ilan Goldberg has interest in Gardening, History Of The Middle East, New Technologies, Hiking, Music, Love Cats, My Family, Travel.
What skills is Ilan Goldberg known for?
Ilan Goldberg has skills like Iso 13485, Fda, Medical Devices, Quality System, Quality Assurance, Capa, Validation, Regulatory Affairs, R&d, Quality Management, Start Ups, Quality Auditing.
Who are Ilan Goldberg's colleagues?
Ilan Goldberg's colleagues are Inessa Dolnik, Efrat Kate Ilovitz, Revital Ivri, Elizabeth Plusnov, Racheli Itayev, Amit Bechar, Ariella Artzi.
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