RAMED, Your Competitive Advantage

DEVOTION | PROFESSION | NORMALIZATION

Solution with 20 Years Experience

RAMED RAMED, Your Competitive Advantage

RAMED (Beijing) Medical Technology Co., Ltd. is a national high-tech enterprise and vice chairman of Clinical Trial Branch of China Association for Medical Device Industry Headquartered in Beijing Zhongguancun Medical Devices Park. The core members of RAMED have worked for world-renowned medical device companies and well-known domestic enterprises. The company aims to provide professional and standardized NMPA and US FDA solutions for the domestic and foreign medical device industry, and to help in transforming of new technologies across countries. RAMED is proud of its team with more than 20 years of experts in China and abroad, also has established strategic partnership with American and European professional associations and incubators, and signed cooperation agreements with domestic industrial parks to share resources and seek common development.

RAMED has provided nearly 100 domestic and foreign medical device and pharmaceutical enterprises with a full set of regulatory services for the production, marketing, sales and use of their products in China, including the establishment of GMP plant and quality management system, research and development verification, clinical trials, product registration and post market management, etc. RAMED also provides regulatory risk assessment for investments and mergers and acquisitions.

RAMED’s services has been certified with BSI ISO13485 that is the international standard specific for medical device industry.

Profession, Devotion and Normalization is our value proposition.

RAMED has set up affiliated offices in Beijing, Shanghai and Boston.

RAMED current existences are:
RAMED Biosciences, LLC
RAMED (Beijing) Medical Technology Co., Ltd.
Shanghai RAMED Medical Technology Co., Ltd.

20Years

20+ Years Experience

Top 500

Work Experience in Multi-national Companies

1000 +

1000+ Cases of Success

360 °

Comprehensive SOP Management

Full Range of Regulatory Solutions
Your Reliable and Private Regulatory Expertise

Clinical Trial / Clinical Evaluation Report

  • Led by Professor Jiankang Wang who has more than 20 years experience in clinical trial & clinical evaluation reports, and has successfully accomplished 1000+ clinical trials for a variety of medical devices.
  • Project implementation team with 12 years average professional experience
  • Integrated solution covering entire process of clinical trial including but not limited to protocol design, data statistics, clinical trial implementation, and GCP management etc.
  • Highly professional Clinical Evaluation Report (CER)

NMPA Product Registration

  • 21 years of experience in NMPA registration for medical devices including IVDs.
  • Registration team with 15 years average experience in NMPA registration
  • All members of the team previously worked in world known medical device companies like BD, Danaher, Thermo Fisher Scientific, Nestle and GE. They have successfully obtained 1000+ NMPA registration certificates for more than 50 manufacturers in the US, Europe and Asia Pacific.

FDA Pre-market Approval

  • Highly professional service offered by American specialists with rich experience in FDA application.
  • Application document preparation
  • Communication with FDA
  • Professional guidance

Regulatory Compliance in Distribution (GSP)

  • Led by experts with 17 years experience of management for 300+ distributors.
  • Providing compliance management services as GSP License, Quality Incident Management/Recall Management and Chinese Labeling, etc.
  • Providing all-round professional services for 3rd party logistics companies to obtain Medical Device 3rd Party Logistics License.

Quality System (GMP)

  • Experts with 20 years GMP practical experience will guide your GMP in China
  • We can satisfy your needs in Process Design, Verification and Validation, Product Release and Quality System Documentation.
  • Wish to export your product to the US? Our experts based in the US can help you in USFDA audit and QSR improvement.

Regualtory Risk Assessment for Investment and Acquisition
New Project Evaluation for Regulatory Risk and Strategy

  • Well-considered analysis on advantage and challenge in regulatory demand. Help client to know how to proactively avoid potential risk in accordance with the NMPA regulations.
  • Investigation service in regulatory compliance such as authenticity of all documents and dossier associated with NMPA product registration, and other potential risks critical to company lifeline.

New Product and Technology Transformation in China

Channel for Importing and Distributing New Product in China

Find Feasible Approaches for New Technology Transformation / Transfer in China

Foreign Expert Technical Guidance to Chinese Innovative Products

RAMED, Your Competitive Advantage Professional Strength

PROFESSIONAL

Each project is strategized and conducted by 5 experts with more than 10 years professional experience, to ensure that the solution is feasible, and as low cost and short lead time as possible.

QUALITY

First and only BSI ISO 13485 certified service in China for professional consultancy services of regulatory affairs and quality management for medical devices including IVDs.

NORMALIZATION

Our creative SOP with copyright ensures quality and standard of the entire process of our service.

EFFICIENCY

High Efficiency in cross-function cooperation management skill gained from previous experience of 20 years in multi-national companies.

Partners

Thinzone International, founded by Thinkzone Group, China's first private hold technology business incubator.Thinkzone International built an unique network to achieve seamless connection between global innovation projects and the China commercial market.

Zhongguancun Medical Device Park was jointly initiated by Zhongguancun Development Group and strategic investor China Communications Construction Co., Ltd. and formally established on October 30, 2012.

The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is a worldwide, non-political organization for clinical chemistry and laboratory medicine. 

The North American Chinese Clinical Chemists Association (NACCCA) is one of the most influential Chinese academic organizations in North America. Members come from the United States, Canada, Europe, China, Singapore, Malaysia and other countries and regions.

Dao Tun is a Basel-based Swiss consulting company specialised in cross-border collaboration between Europe and China, primarily in the healthcare and life science industry.

Amenichi Consulting, LLC is based in Chicago and specializes in drugs and medical device regulatory services. Amenichi is the leading consulting firm in  FDA regulatory, compliance, business development, and market strategy for Japan-related engagements.

eChinaHealth is an integrated media for China healthcare and pharmaceutical segments. It is the new healthcare service under parent company eChinaChem headquartered California.

COMPANY NEWS

Team of Experts & Consultants
Solution with 20 Years Experience

Dr. Jinjie Hu

  • Fomer Senior Reviewer of FDA 
  • 12 years of experience with the Food and Drug Administration, Center for Biologic Research and Review as senior reviewer for multiple analytes In Vitro Diagnostic Devices (IVD) products and CGMP inspection for biologic products.

Dr. Jinjie Hu

Pathology Ph.D.

Consultant

Maurizio Ferrari

  • Maurizio Ferrari, is the President of the European Society of Predictive Medicine, full Professor of Clinical Pathology, University Vita-Salute San Raffaele, Director of Clinical Molecular Biology and Cytogenetics Laboratory, and Head of Genomic Unit for the Diagnosis of Human Pathologies, Division of Genetics and Cell Biology, IRCCS San Raffaele, Milan, Italy.

Maurizio Ferrari

M.D., Ph.D.

Consultant

Jane Shen

  • Executive Director of China Medical Innovation Alliance 
  • 23 years of experience in medical device marketing management in international companies 
  • Former General Manager of Henry Schein China 
  • General Manager of Yuyue Medical 
  • Senior Healthcare Business Director in Asia Pacific and Canada  of BD

Jane Shen

EMBA/Medicine

Brand / Promotion Consultant 

Olia Wang

  • 30+ years of sales and marketing experience in medical device diagnosis industry. 
  • 20 years marketing management experience in international medical device company include 8 years of business strategic management experience in the APAC region.

Olia Wang

Biological

Diagnostic product marketing strategy consultant

Dr. Leon SUN


  • Big data expert of National Health Commission, expert of information center of NMPA.
  • Former FDA Review Leader / Senior Epidemiologist


Dr. Leon SUN

M.D., Ph.D.

Chief Medical Officer

Lei Li

  • Over 10 Years Experience in Biomarker Study for Drug Development, CDx, and Regulatory Affairs.
  • VP of Clinical and Regulatory Affairs, Veritas Genetics.
  • Group head and Senior Principal Scientist in Molecular Medicine, Pfizer Global R&D.

Lei Li

Co-founder of RAMED Bioscience

Co-founder & Clinical Affaires

Ellen Jiang

  • 25 years of work experience in healthcare
  • 21 years of experiences in regulatory affairs, quality system, compliance and government affairs for medical devices
  • Director of Regulatory Affairs & Compliance BD China and Thermo Fisher Scientific

Ellen Jiang

EMBA & Clinical Medicine

Founder & President

Shan WU

  • 11 years of RA experience in medical devices.
  • Rich practical experience in product registration and clinical evaluation
  • Previously worked in Chindex and Biochain

Shan WU

Medical Informatics

Clinical Affairs Director

Cherry Chen

  • 17 years of experiences in regulatory compliance, GSP and GMP in MNC’s. Asia QA Manager for Getinge Infection Control.
  • QA & Compliance Head for BD China & Thermo Fisher Scientific for 8 years.
  • Led compliance work for 5000+ diversified products with $250 Million of sales value.

Cherry Chen

MBA & Engineering

Co-founder & Vice President

Christine Jiang

  • 11 years+ RAQA working experience in Danaher (Leica) and other MNC’s.
  • Rich professional experience in NMPA registration for active instrument.
  • Familiar with ISO 13485, ISO 9001, US FDA CFR820, ISO 9001 Lead auditor.

Christine Jiang

E.E. & Business English

Co-founder. Bioscience