BiotechnologyConformity AssessmentsConsulting ServicesMedical DevicesNotified BodyOtherRegulatory Information ManagementRegulatory IntelligenceSoftware

Metecon

Metecon GmbH

Booth: 100

We are the holistic service provider for regulatory market access. We offer a wide range of consulting and support services to our customers for the verification and validation as well as documentation and approval of their medical devices and IVDs. =========================================================== Technical Documentation ____________________________________________________________________________ Strategic consultation and active support for the preparation and maintenance of technical documentation =========================================================== Clinical Affairs ____________________________________________________________________________ Clinical evaluation via the literature route, clinical investigation, performance evaluation for IVDs, PMS and PMCF / PMPF =========================================================== Regulatory Affairs ____________________________________________________________________________ Consulting services and support for country-specific commercialization =========================================================== Quality Management ____________________________________________________________________________ Quality Management processes in compliance with EN ISO 13485, GxP; audits =========================================================== Medical Device Software ____________________________________________________________________________ Consulting services and support in all regulatory tasks regarding software =========================================================== Verification ____________________________________________________________________________ Verification planning, preparation of test specifications, conduction and documentation of tests, organization and controlling of examinations in accredited laboratories =========================================================== Validation ____________________________________________________________________________ Validation of measuring and inspection tasks incl. software, validation of medical devices / IVDs incl. software, validation of steril processes =========================================================== Testautomation ____________________________________________________________________________ Flexible test automation by means of a six axis robotic system, conduction of experimental runs