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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

Contact:
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

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. 

Contact:
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

Contact:
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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