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Home / Templates

Templates

Showing 1–9 of 20 results

  • Quality Manual Template Part 1 (ISO 13485, Medical Device)

    Quality Manual Template Part 1 (ISO 13485, Medical Device)

    199 € (excl. GST/VAT)
  • Site and investigator qualification questionnaire template (ISO 14155, Medical Device)

    Site and Investigator Qualification Questionnaire Template (ISO 14155, Medical Device)

    99 € (excl. GST/VAT)
  • CAPA form template (13485, Medical Device)

    CAPA Form Template (ISO 13485, Medical Device)

    99 € (excl. GST/VAT)
  • CAPA Procedure Template (ISO 13485, Medical Device)

    CAPA Procedure Template (ISO 13485, Medical Device)

    99 € (excl. GST/VAT)
  • Personnel Procedure Template (ISO 13485, Medical Device)

    Personnel Procedure Template (ISO 13485, Medical Device)

    99 € (excl. GST/VAT)
  • Supplier Evaluation Procedure Template (ISO 13485, Medical Device)

    Supplier Evaluation Procedure Template (ISO 13485, Medical Device)

    99 € (excl. GST/VAT)
  • Use Specification Template (IEC 62366-1, Medical Device)

    Use Specification Template (IEC 62366-1, Medical Device)

    99 € (excl. GST/VAT)
  • Risk Management Procedure (ISO 14971, Medical Device)

    Risk Management Procedure Template (ISO 14971, Medical Device)

    99 € (excl. GST/VAT)
  • Clinical investigation submission letter template feature image

    Clinical Investigation Submission Letter Template (ISO 14155, Medical Device)

    49 € (excl. GST/VAT)
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  • Blended courses
    • Design Control
    • Project Management for Product Development
    • Risk Management and ISO 14971:2019
    • Safety for Medical Devices and IEC 60601
    • Software for Medical Devices
    • Usability Engineering
  • Online courses
    • Clinical Investigation and ISO 14155
    • Design Control
    • Medical Device Regulation
    • Project Management for Product Development
    • Quality Management and ISO 13485
    • Risk Management and ISO 14971
    • Safety and IEC 60601
    • Software and IEC 62304
    • Usability Engineering and IEC 62366-1:2020
    • Introduction to working in the medical device industry
  • How to – short online courses
    • Design and Development Plan
    • Risk Management Plan
  • Templates

Would you like to learn more about risk management or design control?

Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course.
These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.

Company details

Gantus AB, Björkvägen 14, SE-224 56 LUND, Sweden,
Corporate ID: 556736-4541,
VAT No: SE556736454101,
Location: Malmö, Sweden

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Recent posts

  • Policy for establishing criteria for risk acceptability according to ISO 14971:2019
  • The illustrated guide to quality management for medical devices and ISO 13485
  • Education and training requirements for the PRRC under the MDR: Meeting auditors’ expectations
  • Design risk assessment, process risk assessment, and use risk assessment for medical devices – the danger of division (Part 3)
  • Design risk assessment, process risk assessment, and use risk assessment for medical devices – the danger of division (Part 2)
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