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Clinical Affairs

You are here: Home1 / Academy2 / Inhouse-Seminars3 / Clinical Affairs

Clinical evaluations and clinical investigations require medical, technical, and methodological expertise.

Offer your employees professional training on this topic so they can always stay up to date!

  • Clinical evaluation of medical devices according to MDR
  • Performance evaluation of IVDs according to IVDR
  • Events and Seminars
    • Registration
  • Seminar topics
    • Quality management training
    • Training Medical Device Advisor
  • Certificate-Courses and MBA
    • Online course: Regulatory Specialist MDR-IVDR
    • MBA Health Tech Management
    • Online-Certificate Course: Medical Software Specialist
  • Inhouse-Seminars
    • basic course IVDR
    • basic course MDR
    • Change management for medical devices
    • MDR / IVDR
    • MDR or IVDR gap analysis
    • Technical Documentation
    • Clinical Affairs
    • International
    • In vitro diagnostics – IVDR
    • Medical Devices – MDR
    • Cybersecurity
    • Development of software for medical devices
    • IEC 62304 and IEC 82304-1
    • IEC 62366-1: UX and usability for medical software
    • ISO 13485:2016 Basic course
    • Medical Software & Apps
    • Risk management for medical device software
    • Standards & norms
    • Internal audits ISO 13485
    • Quality Management
    • Regulatory Affairs
    • ISO 9001:2015
    • Start Ups
    • Development & Processes
    • Medical device advisor
    • ISO 14971 risk management
    • GSPR active medical devices
    • GSPR for In Vitro Diagnostics
    • GSPR for Non-Active Medical Devices
    • EN 60601 – Medical electrical equipment
    • Installation, maintenance, and testing of medical devices
    • ISO 10993 – Biocompatibility
    • Medical Device Operator Ordinance
    • Medical Devices Implementation Act (MPDG, Germany)
    • Medical Devices Operator Ordinance (Germany)
    • Medical Software & Apps
    • Usability
    • Clinical evaluation & testing
    • Clinical performance evaluation of IVDs
    • Post Market Surveillance
    • Labelling and Unique Device Identification (UDI)
    • Labeling with UDI
    • FDA – Approval for medical devices
    • MDSAP-Audittraining
    • Quality management requirements in the USA

Our contact details

en.co.tec Schmid KG
Breitenfurterstraße 401-413/25/R1
A-1230 Vienna / Austria
Phone: +43 1 8863491
office@encotec.at

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