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Beijing Believe Technology Service Co

Professional medical regulation and quality system consulting to CE mark and CFDA and FDA 510(k).  www.believe-med.com

Contact:
Yue Guan, Sales Manager
yue.guan@believe-med.com, Phone: +86-18910677558
Languages: Chinese, English

Location: China

Biomedical Strategy Ltd

BioMedical Strategy, led by Dr. Orna Oz, is a unique and highly qualified consulting group providing pre-clinical, clinical and regulatory strategic planning. We are committed to delivering healthcare product companies with the utmost efficient and cost-effective approach for product entry to the world markets, including the U.S., Europe, Israel and elsewhere. For further information visit www.ebms.co.il

Contact:
Orna Oz, Chief Excecutive Officer
Orna@ebms.co.il, Phone: +972-3-6123281
Languages: English, Hebrew

Locations: Israel

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

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

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

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

Shanghai QiSheng Business Consulting Co., Ltd.

Qisheng focuses on providing regulatory consulting service for medical device manufacturers. Qisheng have confidence in helping medical device manufacturer launch their product in designated market as soon as possible by leveraging its expertise and professional service. QiSheng team has around over 30 years of experience in the medical device field. For further information visit www.qishengbc.com

Contact:
Daniel Qiu, General manager
daniel.qiu@qishengbc.com, Phone: +86-18616628661
Languages: English, Chinese (Mandarin)  

Locations: China

Talmed Ltd

Talmed – Medical Devices Regulatory and Quality Consultancy Ltd. (Talmed) has been established at 2010 by Tali Hazan, who worked until that time (from 1989 until 2009) in the QA and RA industry and from 2009 to 2010, as an independent consultant. The company is privately owned and located in the north of Israel (Upper Galilee). It serves tens of customers in various QA and RA topics related to wide variety of medical devices. Four staff members currently work at Talmed and more are expected. Among our customers there are small start-up companies as well as large well-established companies. We provide close attention to each customer, identifying specific needs in order to provide best advice and working frame to each customer, we make any effort to make regulations as accessible and clear as possible.

Contact:
Tali Hazan, RA Consultant
tali.hazan@talmed.co.il, Phone: +972-50-5292304
Languages: Hebrew, English, Arabic

Locations: Israel

VOLER Biotech Consulting Co. Ltd.

VOLER Biotech Consulting Co. Ltd. was established in 2017. It is composed of an experienced team who assist biotechnology industry in testing and regulation affair of medical device, health food/health supplement product, pharmaceutical, cosmetics and chemical registration. We provide full scope regulation service include quality system, technical documents for CE and FDA submission, experiment design and validation and product registration strategy planning. We assist our client complete all documents and get government product certification successfully. For further information visit www.voler.com.tw/

Contact:
Howard Kao, Vice president
leon.howard01@gmail.com, Phone: +886 02 25035698 and +886 07 8419003
Languages: Chinese,  English

Locations: Taipei, Kaohsiung

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