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Estaslished in July 2000, Jens Medical Consulting is a Contract Research Organization (CRO) dedicated to assist medical device manufacturer in exploring the complicated regulation worldwide, espeically small entity that doesn't have their regulatory team or new player in the medical device field including In-vitro diagnostic device manufacturer. Our Regulation consultant could assist in establish Quality Managment System and Technical Documentation in compliance with Taiwan FDA, US FDA, Health Canada, EU Medical Device Regulation in terms of medical device, pharmaceutical product including generic drug, API, OTC or new drug, medication cosmetics and food supplements.  You may benefit from our value added professional consultancy in time saving and cost effective manner. Headquartered at Taipei, Taiwan, Jens Medical established regulatory strategy alliance will facilitate the global market entering swiftly such as US FDA, Health Canada, EU member, Russian MOH, Japan PMDA, ASEAN countries …
 
As a contract reserach organization, we have medical doctors as our consultant to conduct medical device clincial study in hospitals. Jens Medical offers comprehensive regulatory affair and medical affair services on medical device regulation from the very beginning at the product design stage, prototype testing, small scale production to post-marketing surveillance, including Quality System Compliance Consulting (GMP/ISO 13485/MDSAP/GDP), Preclinical Testing Consulting (IEC Electric Safety, EMC, Biocompatibility, Fuctional Test, Performance Study, Usability Study, Risk analysis, Software Validation, Sterilization validation…), ISO 14155/GCP compliance clicnial Study/clincial investigation and clincial assessment, medical device documentation preparation in STED format, US 510K Premarket Notification, Quality Managment System establishment for quality system certification by notify body, Establishment Registration and Device listing, EU Authorized Representative, US Agent, Taiwan license holder and Distributor hunting.