We bring the knowledge to you and turn you into “qualified personnel”.

MEDTECH360 offers you customized training in the following areas:

  • Medical technology basic training,

    • Regulatory framework,
    • Authorities,
    • economic areas,
    • Requirements and restrictions for a medical device,
    • standards,
    • Conformity assessment procedures,
    • Basic safety and performance requirements,
    • Intended use,
    • Classification of medical devices


  • Quality management according to EN ISO 13485

    • Management systems and how to work with them
    • Strategies to install a quality management system
    • How the standard is structured
    • Basics of quality management (control of documents, management tasks, product procedures, improvement procedures)
    • Effort to install a QM-System


  • Risk management according to EN ISO 14971

    • General Risk Management Requirements
    • Risk Management Plan
    • Risk Analysis
    • Risk assessment
    • total residual risk
    • Risk management report

Trainings can be conducted on-site or virtually.
Ask us, we will provide you with a non-binding offer.