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    Medical devices

    Medical device software process design based on IEC 62304

    This two-day course, in cooperation with Intertek Academy, focuses on how to design a process for the development and maintenance of medical device software according to the IEC 62304 standard and the regulatory requirements that apply to medical device software.
     

    Topics

    • Current software practices
    • Designing high quality software in a regulated environment
    • Standards for regulatory compliance
    • Implementation examples for achieving compliance
    • Practical applications of the requirements of the 62304 standard
    • Some possible future changes within the medical device software field

    Trainers

    Maria Rickardsson
    Maria Rickardsson
    Senior Quality and Regulatory Consultant
    Maria is a senior QA/RA specialist with more than 20 years of experience in the medical device industry, specializing in medical device software development and software lifecycle processes. She has extensive expertise in IEC 62304, quality management systems, risk management, and regulatory affairs, helping organizations navigate the full product lifecycle from concept and development to market access and post-market compliance. Her experience spans both consulting and leadership roles in innovative medtech and digital health companies. In addition, Maria has been a member of the IEC 62304 standardization group, contributing to the development of the internationally recognized software lifecycle standard for medical devices.

    Target group

    This course is targeted towards professionals working with the development of medical devices containing software or software as a medical device (SaMD), with risk assessment of software-based products, quality assurance, process improvements, with the purchasing of software development from subcontractors, or purchasing software components. A basic understanding of the medical device regulations and some product and software development experience is recommended.

    Objectives

    After the course, participants will have an understanding of how to employ design processes for medical device development based on the 62304 standard, in order to achieve regulatory compliance and how to design high quality software in a regulated environment.

    Additional information

    The course costs 15 200 SEK (excluding local VAT). The course material is in English, with verbal presentation and discussions in Swedish or in English, depending on the participants.

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