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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

Epin Shanghai Ltd

EPIN, as a Thrid-Party medical testing laboratory, we focus on medical industry. We supply one-stop service, such as R&D Study Outsourcing, Third-Party Testing, Preclinical Study, Animal Experiment, Technical Consulting, Training, and CFDA/FDA/CE registration services, for various medical device manufactures and scientific research institutions. EPIN’s testing reports are widely recognized at home and abroad. We comply with ILAC ISO 17025 and FDA GLP system, and have been accredited by CNAS (China National Accreditation Service for Conformity Assessment) and IAS (The International Accreditation Service). For further information visit www.epintek.com

Contact:
Stefanie Sun, Sales Manager
stefanie.sun@epintek.com, Phone: +86 21-5463 6833
Languages: Chinese

Location: China

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

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

Qualtech Consulting Corporation

Qualtech is a Medical Device Consulting Company and Clinical Trial Organization (CRO), with a focus on East Asia and the ASEAN nations of South-East Asia. With over 19-years of immense experience serving clients worldwide in Medical Device Registration and Regulatory affairs, specializing in China, Taiwan, Singapore, Hong Kong, Malaysia, the Philippines, Indonesia, Thailand, and Vietnam registrations, QUALTECH is your ideal partner to gain strong access to the fast evolving Asian markets. Recognized widely for our professional knowledge and management excellence, Qualtech can further serve as your local authorized representative in Asia, provide CER writing, and can conduct your clinical trial. Therefore, offering a one-stop solution for the Asian medical device markets. www.qualtech.com.tw

Contact:
Yin Pen Chang, Chief Excecutive Officer
drchang@qualtech.com; irene@qualtechs.com; Phone: +886-227401778
Languages: Chinese Mandarin, English, Japanese, Tagalog, Melayu, Indonesian, Cantonese, Vietnamese, Thai

Locations: China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam

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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