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    Medical devices

    Health Tech Regulations, Quality Management and Commercialization

    This is a health tech regulation, quality management and commercialization training for R2Bs and startups.

    This is a health tech regulation, quality management and commercialization training for R2Bs and startups. The commercialization of innovations is always a challenge, but it is especially a challenge when the product is strictly regulated, as in the health technology sector. Come and hear the basics of quality management systems and the commercialization of medical devices. In addition to the training day, you will receive 60 minutes of personal sparring on your key challenges in understanding medical device commercialization or regulatory framework, allowing you to concentrate on the special features and needs of your own innovation!

    Topics

    • Innovating in a regulatory industry
    • Commercialization of medical devices
    • Quality management according to ISO 13485
    • Medical device development (IEC 62304, ISO 14971)
    • 1-to-1 sparring

    Target group

    Research to business teams (R2Bs) and accelerators, startups, and individuals working in health tech innovations. 

    Objectives

    • You will learn the most common standards used in the health tech field and how to apply them in practice.
    • You will know the most common pitfalls in the commercialization of medical devices.
    • You can increase the skills to support the implementation of the regulatory strategy and gain new competencies in quality assurance and regulatory affairs.
    • You will ensure competitiveness and the common interests sought by action.
    • Personal sparring ensures your ability to innovate, learn continuously, collaborate, and develop.

    Additional information

    The training is suitable for individuals starting the commercialization or preparation of a medical device, whether a physical device or software. It will be conducted in English, and training materials will be available after the training.