RAMED, Your Competitive Advantage

DEVOTION | PROFESSION | NORMALIZATION

Solution with 20 Years Experience

RAMED RAMED, Your Competitive Advantage

RAMED is the first company in China jointly established by world known medical device technological service experts and regulatory affairs experts, and is specialized in new medical technology transfer, product incubation and regulatory affairs service. The aims of the company are to provide the medical device research institutions and the industry in the world (mainly China and USA) with industrialization operation and high quality professional regulatory compliance solution covering the entire life cycle of the product.

RAMED experts from China and other countries, with more than 20 years of professional experience, will deliver an integrated technical implementation and regulatory compliance process covering GMP plant establishment, quality system management, R&D verification, clinical trial, product registration and post market management, etc., to those who have products to be manufactured, marketed and used in China; and provide regulatory service like the USFDA pre-market approval and GMP management to those who have medical devices to be exported to the US. In addition, we also provide regulatory risk assessment for investment and acquisition.

RAMED is currently the only BSI ISO 13485 certified service in China for professional consultancy services of regulatory affairs and quality management for medical devices including IVDs. RAMED has copyright for several SOPs established with 20 years professional experience to ensure high quality of its service.

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.

Our Valuable Clients

COMPANY NEWS

Team of Experts
Solution with 20 Years Experience

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

Jiankang Wang

  • Visiting professor of NMPA institute of Executive Development.
  • Involved in compiling clinical trial guidance and NMPA registration review as expert invited.
  • Invited guest and speaker at China International Medical Device Forum.
  • 20years experience in clinical trail for medical device and grug.

Jiankang Wang

MS of Clinical Medicine
VP for Clinical Trial

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
RA Development 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

Lynn Gu

  • 20 Years+ GMP management experience in manufacturing medical devices
  • Familiar with ISO 13485 and NMPA requirements in GMP.
  • VP for quality in Shanghai Kehua Bio-engineering Co.,Ltd (1995-2015).

Lynn Gu

MS of Biology & MBA
Vice President of Quality System

Judy Liu

  • 10 years of RA working experience in MNC’s.
  • Success in 200 NMPA certificates for imports.
  • Strength for IVD and blood screening reagents.
  • Involved in 10 national/industrial technical standards and 3 technical review guideline for NMPA

Judy Liu

MS of Biochemistry and Molecular Biology
Co-founder & Regulatory Affairs

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