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  • design_development

    Design and development plan template (medical device per ISO 13485 and 21 CFR 820)

    This template will provide you with a framework to complete your design and development plan. It may also be used as a benchmark on your existing plan. The template includes topics as required by clause 7.3.2 of ISO 13485:2016 and §820.30(b) as required by 21 CFR 820.

    $49.00 MORE INFO
  • design_development

    Design and development plan template (medical device per ISO 13485 and 21 CFR 820) Free

    This is a free template. A premium version of this template is available for purchase on the website.

    This template will provide you with a framework to complete your design and development plan. It may also be used as a benchmark on your existing plan. The template includes topics as required by clause 7.3.2 of ISO 13485:2016 and §820.30(b) as required by 21 CFR 820.

    Free! MORE INFO
  • design_control

    Design control for medical devices

    2-day course, course certificate

    This two-day course provides you with knowledge about how to work with design control in a medical device product development project. The course is aimed at those involved in the development of medical devices and who are responsible for meeting design control requirements such as QA, project management, design engineering, or who are members of R&D or new product development teams.

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  • Project-charter-img

    Project charter template

    This template will provide you with a framework to complete your project charter. It may also be used as a benchmark on your existing charter. The project charter is not a regulatory document per se, but many auditors will ask for the starting point or decision to start a project, and then the project charter would be the answer.

    $29.00 MORE INFO
  • project_management

    Project management for product development of medical devices (4 days)

    4-day course, course certificate

    This is a four-day course that will provide you with information on how to manage a product development project within the medical device industry. The course is suitable for junior project managers and project managers who have not previously worked with medical devices and other personnel involved in product development.

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  • Gantus Quality Management System

    QUALITY MANAGEMENT SYSTEM
    (EN ISO 13485 AND 93/42/EEC)

    A full quality management system according to annex II of the medical device directive and ISO 13485:2016.

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  • hazard_trace

    Risk analysis/Hazard traceability matrix template

    This is a downloadable template which applies to medical devices, including in-vitro diagnostic medical devices and active implantable medical devices. It includes useful spreadsheets to document the outputs from your risk management activities. It will help you achieve conformity with clauses 4.2, 4.3, 4.4, 5, 6.1, 6.2, 6.3, 6.4 and 6.7 of the ISO 14971:2007, 2009 and 2012.

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  • risk_management

    Risk management for medical devices and ISO 14971 online training

    Free 30 minute online taster course, course certificate

    We provide a free, web-based 30 minute taster course to give you an introduction to risk management. The full course  equips you with a course certificate and – naturally – a great deal more information on how to perform risk management according to ISO 14971.

    $299.00 MORE INFO
  • risk_management_plan

    Risk management plan template (medical device and ISO 14971)

    This template will provide you with a framework to complete your risk management plan. It may also be used as a benchmark on your existing plan. The template includes topics as required by clause 3.4 of ISO 14971:2007, 2009 and 2012. It also includes topics that should be addressed for software risk management according to IEC 62304:2006.

    $49.00 MORE INFO
  • risk_management_plan

    Risk management plan template (medical device and ISO 14971) Free

    This is a free version. A premium template with more content is available on the website.

    This template will provide you with a framework to complete your risk management plan. It may also be used as a benchmark on your existing plan. The template includes topics as required by clause 3.4 of ISO 14971:2007, 2009 and 2012. It also includes topics that should be addressed for software risk management according to IEC 62304:2006.

    Free! MORE INFO
  • risk_management_procedure

    Standard Operating Procedure (SOP) for risk management according to EN ISO 14971

    This is a downloadable template for a standard operating procedure on risk management documenting a process as required by the ISO 14971. It will help you achieve conformity with most requirements in ISO 14971. The template includes instructions and information on sections that are particularly important or may require explanations.

    $99.00 MORE INFO
  • Status-report-full-img

    Status report Template (Full)

    This is a free template.

    This template will provide you with a framework to help you summarize and communicate project status to the steering group and management

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