Our Services

◆ Medical device overseas registration service

Mr.Tech group provides the best bridge for medical companies to enter the overseas market. The Asian consultant team has many years of experience in international regulations. It is our goal to avoid language barriers and provide online consulting services in real time, as well as quickly assisting customers to receive registration certificate, No matter which country you choose to sell in, we provide a complete one-stop solution. We can help your medical products to accelerate into the international market by our years of regulations and   registration experience,
 
◆Mr.Tech group’s service

International medical device registration service-----Years of experience in international regulations, free of language barriers, instant online consultation, quick registration, the best bridge for medical companies to enter overseas markets
 
Quality system training and consulting-----Have many years of experience in medical device factory quality assurance department consultants and former international certification company regulations, help you to complete quality system audits, and ensure your products
 
OECDGLP

Medical instruments
Biocompatibility test------OECDGLP certified laboratory, professional test scheme design, you can correctly screen the hazards and risks that may arise from product materials or manufacturing processes, and provide your international-level certified report
 
Regulations training services-----we can assist new employees in the company to understand the life cycle of medical device products and analyze the quality system. We have comprehensive curriculum planning to help companies enhance their international competitiveness.
 
◆ Our Service

America FDA

 510 (K) application (MD&IVD)
  PMA application
  De Novo application
 Pre-submission Service (pre-review application and consulting services)
  Listing (registered column name)
 
EU CE

 EU medical device CE regulation counseling service
  CE technical file establishment and consulting
  ISO13485 quality system construction consultation
  Clinical Evaluation Report
  POST MARKET CLINICAL FOLLOW-UP (PMCF) and Post Market Surveillance (PMS)
  Euro Rep login service
  EU Notified body SZUTEST (CE2195)
  MDR CE Mark counselling consultation
 
Taiwan, Korea, India, Singapore

 Taiwan TFDAI/II/III medical materials registration
 Korea KFDA/India/Singapore International Registration
 
◆ Advantages of Mr.Tech group

1. More than ten years of regulatory experience
2. More than 1500 product testing experience
3. More than 500 FDA&CE product registrations
4. Message reply within 24 hours