RAMED, Your Competitive Advantage

PROFESSION | NORMALIZATION | EFFICIENCY | DEVOTION

Solution with 25 Years Experience

RAMED RAMED, Your Competitive Advantage

Ramed (Beijing) Medical Technology Co., Ltd. (below as RAMED) 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 25 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 became a subsidiary of Pharmaron (stock code: 300759.SZ / 3759.HK).

RAMED has provided services for over 200+ domestic and foreign clients, and has accumulated experience of 1000+ successful cases. The services that provided by RAMED range from the establishment of GMP plants, quality management system, R&D compliance, whole process service of clinical trial, and product registration (including on-site services). Meanwhile, RAMED also provides third-party audit services for medical institutions, provides US FDA pre-market approval services for medical device products exported to the United States; and provides regulatory risk assessment for investments and mergers and acquisitions.

RAMED’s strict requirements for "service quality" have been the constant pursuit since its establishment. Therefore, RAMED takes the lead in the regulatory service industry for medical device and has been successfully certified with BSI ISO13485 quality management system, and has independently developed a number of management processes and software.

Profession, Normalization, Efficiency and Devotion is our value proposition.

25Years

25+ 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

RAMED Kick-off Activity in the United States

Team of Experts & Consultants
Solution with 25 Years Experience

Wenhui Liu

  • 20 years of experience in medical device, IVD, and drug development, registration, and clinical trials
  • Previously worked at GlaxoSmithKline, GE Healthcare, ThermoFisher Scientifc and Burning Rock
  • Deeply participate in the entire process of converting multiple first registered projects of the same variety
  • Familiar with domestic and CE registration regulations

Wenhui Liu

Pharmacy

Director, Business Development

 

May Zhou

  • 10 years of experience in MNCs and domestic medical device regulatory affairs
  • Familiar with medical device regulatory regulations in China, US, Europe, Australia,etc.
  • Proficient in domestic and international high-risk product registration, EU CE certification
  • Familiar with the full lifecycle regulatory affairs and quality management of medical devices
  • RAC-DEVICE holder

May Zhou

International Project Management, Master

Director, Regulatory Affairs

Wendy Yu

  • 10 years of experience in medical devices and in vitro diagnostic (IVD) product registration and clinical affair
  • RAC holder for Medical Devices from the RAPS
  • 100+ projects, proficient in CER, OCTD, clinical trial design and statistical analysis
  • Participated in China Medical Device Innovation and Development Report for the Ministry of Science and Technology

Wendy Yu

Pharmacy, Master

Associate Director, Clinical Evaluation

Ying Zhang

  • 14 years of experience in the development and transformation of molecular diagnostic products
  • Previously worked at Crown Bioscience, Annoroad and Microread
  • Proficient in the R&D and clinical protocol design of IVD with experience in Class III product projects of 50+
  • Independent inventor of 3 molecular diagnostic technology invention patents

Ying Zhang

Biochemistry and Molecular Biology, Master

Manager, Medical Affairs

Jeffrey Zhang

  • 14 years of experience in active medical device research and development
  • Previously worked at  Philips healthcare and Medtronic
  • Familiar with the development of active medical device hardware, systems and products
  • Experienced in design, diagnosis, testing, modification and certification of active medical device safety and EMC

Jeffrey Zhang

Mechatronics, Master

Associate Director, R&D Compliance

Cherry Chen

  • 20 years of quality management experiences
  • Previously worked as QA & Compliance Head for BD China, Thermo Fisher Scientific and Getinge Infection Control
  • Established ISO13485 Quality Management System which was the first BSI ISO certified regulaoty consulting services for medical device in 2016
  • Implement Ramed Standardiz-ation Management

Cherry Chen

MBA & Engineering

Senior Director, Quality & Training

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

 

Dr. 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

Dr. Lei Li

Co-founder of RAMED Bioscience

Co-founder & Clinical Affairs

Ellen Jiang

  • Leading director member of Clinical Trial Association for Medical Devices of China Association for Medical Devices
  • Director of Regulatory Affairs & Compliance BD China (1996-2010)
  • Director of Regulatory Affairs & Compliance Thermo Fisher Scientific (2012-2015)
  • Member of  The 5th Committee of SAC/TC136
  • Member of The 1st Committee of SAC/TC338/SC1

Ellen Jiang

EMBA & Clinical Medicine

Founder & President

 

Shan Wu

  • 15 years of experience in clinical trials, CER writing, and registration of IVD and device products
  • Previously worked  at Biochain and Chindex
  • Managed over 70 multicenter clinical trials for Class III products, responsible for and participated in the registration of over 150 products
  • Led third-party audits of over 100 medical device clinical projects

Shan Wu

Medical Informatics, Master

Executive Director, Clinical Affairs