Synergy MedTech (Suzhou) Co., Ltd hereafter, referred to as Synergy is dedicated to “empowering the entire lifecycle of medical device”: solving challenges at different stages from R&D to market launch. We help companies shortening R&D cycles, Leading-in regulation and standard requirements, enhancing quality management systems, Identifying and manage high level risks, to accelerate product registration processes as well as fulfill post market surveillance. Synergy provides "end-to-end" precise integrated services for different phases of the medical device lifecycle. Synergy has gathered nearly ten compliance experts involved in medical devices and IVD fields, covering R&D, quality management, production & operation management, global registration and certification.
QMS establish (GMP/GSP, MDSAP, ISO 13485, QSR 820)
Regulation introduce, MD classification, registration strategic, Usability research
Design procedure, Risk Management, usability engineering, software development, cybersecurity, design verification and validation
Type testing, Brazil INMETRO, Usability summative testing, Cybersecurity, Reprocessing, 21 CFR Part 11 Verification and validation
CE MDR/IVDR
FDA510K
NMPA
MDSAP/ISO 13485
Adverse event monitoring
Risk analysis
Design change control
PSUR(Periodic Safety update report)
PMCF(Post Market Clinical Follow-up)
