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Malca Chen-Zion

Malca Chen-Zion Consulting Group provides clinical and regulatory consulting services related to the research and development of medical devices and related technologies. With her extensive knowledge and experience, Dr. Chen-Zion guides client-partners through the entire process, from initial concept to regulatory plan, including testing, preclinical, clinical trials, pre-marketing clearance and post-marketing compliance. The full range of regulatory and clinical consulting services, tailored to meet each client-partners' specific needs, assists companies in product entry to the world market, including Israel, Europe, USA and elsewhere. For further information visit www.chenzion.com

Malca Chen-Zion, Clinical and Regulatory Affairs Consultant
malca@chenzion.com, Phone: +972-52-2420702
Languages: English, Hebrew

Locations: Israel

Mid-Link Consulting Co., Ltd

Established in 2005, Mid-Link Consulting Co., Ltd has been focused on providing medical device & Pharmaceutical regulatory consulting. With offices in Houston, Vancouver , Beijing ,Tianjin ,Jinan, Shanghai, Suzhou, Shenzhen, we provide our services to device and pharmaceutical companies around worldwide, which include consulting services of global regulatory strategy, pre-market application, regulatory compliance, quality system management, as well as assorted services of training and local representative. For further information visit www.mid-link.net

Contact: James Huang, Sales Director
sales@mid-link.net, Phone: +86-400 821 7661
Languages: Chinese, English 

Locations: China, USA, Canada


MedRegS, a boutique medical devices' consulting firm, was founded in Israel on January 2012 by Mr. Miki Sahar in order to accompany and support start-ups as well as mature companies in dealing with QA and RA matters related mainly to the USA, Europe and Canada. Mr. Sahar has been engaged in the Bio-medical industry in Israel since 1991, focusing on regulatory affairs, quality assurance, pre-clinical and clinical trials and product validations and testing. He has served in these capacities in several start-up companies, as an engineer as well as a director. In addition to the start-up companies, he worked at KEMA (currently Dekra) as their first Israeli auditor covering quality management systems and CE mark applications. Mr. Sahar has a B.Sc. in Aeronautical engineering from the Technion, an M.Sc. in Bio-medical engineering from Tel-Aviv university and an MBA from Manchester university. 

Miki Sahar, General Manager
medregs@12net.net; medregs01@gmail.com, Phone: +972-54-5430303
Languages: English, Hebrew

Locations: Israel

ProMedoss, Inc.

ProMedoss was created to support medical device startups and entrepreneurs to bring medical devices to market in a fast, efficient, and cost-effective way. We provide services which include full support in regulatory compliance, clinical trials, quality management systems, risk management, and due diligence. For further information visit www.promedoss.com

Bosmat Friedman, Head of Regulatory & Clinical Activities
E-mail: bosmat.f@promedoss.com, Phone: +1 647-975-3974
Languages: English, Hebrew

Locations: USA, Canada, Israel

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