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Estaslished in July 2000 Taipei Taiwan, 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 Taiwan FDA, US FDA, Health Canada, EU product registration for medical device, medication cosmetics, pharmaceutical product including generic drug, API, OTC, medication cosmetics and food supplements for premarket apporval. 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 CE marking, Russian MOH, Japan PMDA, Brazil ANVISA …
 
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), Preclinical Testing Consulting (IEC Electric Safety, EMC, Biocompatibility, Fuctional Test, sterilization validation…), ISO 14155/GCP compliance clicnial Study, medical device registration submission package preparation such as Technical Construction File preparation in STED format for CE marking, US 510K Premarket Notification, Quality System establishment for quality system certification by notify body, Establishment Registration, EU Authorized Representative, US Agent, Taiwan license holder and Distributor hunting.