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L.S. Marketing & Registration

Our team comprises professionals from the Medical Device field – the team is proficient, focused, and includes first class medical regulatory experts in medical devices regulation, import of medical equipment, ISO 9001 audit preparation, dossier preparation – Israeli AMAR registration FDA, CE, ISO 13485 and 9001, FDA- all classes, business development of companies, establishment of a global network of distributors, and professional consulting focused on the medical fields, management of international trades- all aspects of import and export Israeli registration Holders services , Israeli RA rep. www.ls-amarandmore.com

Contact:
Shuky Nadel, Managing Director
liat2710@zahav.net.il, Phone: +972 54 8058871
Languages: English, Hebrew, German, French and Arabic

Location: Israel and Europe

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

OMER-QA & RA Ltd.

OMER-QA & RA LTD focuses on helping medical devices companies of all sizes in achieving their regulatory goals by walking them through the quality management system requirements and regulatory activities till goal is achieved. We are hands-on consultancy, with many years of experience and vast technical knowledge.

Contact:
Asaf Omer, Chief Excecutive Officer
asaf@omer-qara.com, Phone: +972-544318812   
Languages: English, Hebrew

Locations: Israel

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