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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, espeicallysmall 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 establishing Quality Managment System and Technical Documentation in compliance with Taiwan FDA, US FDA, HealthCanada, EU Medical Device Regulation.As a contract reserach organization, we have medical doctors as our consultant to conduct clincialstudy in hospitals in compliance with GCP. You may benefit from our value added professional consultancy in time saving and costeffective manner.Headquartered at Taipei, Taiwan, Jens Medical established regulatory strategy alliance willfacilitate the global market entering swiftly such as US FDA, Health Canada, EU market,Japan PMDA, ASEAN countries …Besides medical device, we could deal with Taiwan FDA filing in terms of pharmaceutical productincluding generic drug, API, OTC or new drug, medication cosmetics and food supplements. Jens Medical offers comprehensive regulatory affair and medical affair services on medical deviceregulation from the very beginning of product design stage, prototype testing, small scale productionto post-marketing activities such as:

  • Quality System Compliance Consulting and Establishing (QMS/ISO 13485/MDSAP/US QSR),Quality System Documentation Writing, Conducting Exteranl Auditing before Notify Body(NB) Certification or FDA on-site inspection.
  • RA consulting and technical documentation writing including  Preclinical Testing Consulting (IEC Electric Safety, EMC, Biocompatibility, Fuctional Test, Performance Study, Usability Study(ISO 62366), Risk analysis (ISO 14791/ISO 24971), Software Validation (ISO 62304),Sterilization validation…), technical documentation in STED format, US FDA 510K Premarket Notification.
  • Clinical Evaluation (CER), Clinical Study (Clinical Investigation) or postmarket clinical follow up (PMCF) in compliance with  ISO 14155/GCP,
  • Postmarket activities including postmarket surveillance (PMS), periodic safety update/PSUR,,medical device technical documentation in STED format,
  • Acing as license holder such as US agent (including Establishment Registration and Device listing), EU Authorized Representative (EUDAMED registration ), UK authorized representative to register with Medicines and Healthcare products regulatory agency (MHRA) for the markets in great Britain and Northen Ireland, Swiss authorized representative, Taiwan license holder and Distributor hunting.