Synergy MedTech Co., Ltd
 
 
Synergy MedTech Co., Ltd

01 Active medical device Senior expert teamAll team members bearing over 15 years of experience in medical device research and development from well-known foreign companies, engaged in research and development testing and global market regulatory access registration. Dedicated to medical device system R&D, compliance testing, and global registration support. Proficient in domestic and international standards and regulatory requirements, solving difficult deficiencies in NMPA issues, as well as project managing throughout the whole lifecycle.02 Active Medical Device Compliance TeamMembers have worked for medical device manufacturers and third-party testing and certification agency for more than 10 years, with experience in regulatory registration/system assessment for multiple high-risk devices in Class II and Class III. Having a multi perspective understanding of compliance requirements, have assisted several renowned manufacturers in compliance testing and QMS evaluation. Brazil INMRETRO ABNT NBR, ISO 13485:2016 auditor, CCAA auditor.03 Software Cybersecurity Project TeamTeam members have over 10 years of experience in the research, development, and registration of medical devices. They were former senior technical managers at leading global medical device manufacturers responsible for FDA/NMPA/CE software registrations (including cybersecurity). They excel at guiding software system documentation compliance as well as fulfill guidance on software and cybersecurity design improvements.04 IVD Product Senior Quality Regulations TeamTeam members have more than 10 years of registration experience, proficient in requirements of both ISO13485 QMS and regulatory registration in China, the EU and North America. Skilled in the integration and construction of Global QMS and China Local GMP/GSP/NMPA. Have guided global market access for multiple IVD products, including independent software products.05 Senior Consulting Project Management TeamTeam members have over 15 years of experience in medical industry and are familiar with the global market access requirements. Previously worked for the UL and the DEKRA Suzhou Medical Team. Fluent with FDA/CE MDR/IVDR directive requirements and application procedure. Familiar with SaMD and Cybersecurity compliance requirements, skilled in handling complex cases, and providing total solutions for leading enterprise.06 Regulatory Registration TeamAll team members are medical device regulatory experts proficient in FDA 510 (k), CE/MDR certification, risk management, human factors engineering, clinical evaluation, software validation, special process validation, etc. Particularly skilled in QSR 820 QMS construction, mock audit, and FDA QSR 820 accompanying audit.

Business consulting

Phone:+86 13806203941

Email:info@synergy-medtech.com

Copyright © 2024 SYNERGY All Rights Reserved 苏ICP备2024060610号-1