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    Medical devices

    Cybersecurity standards for medical devices

    This course provides a general overview of current standards within cybersecurity for medical devices, and an overview of the cybersecurity requirements in the IVDR and MDR.
     

    Topics

    • Background – what sets medical devices apart?
    • Requirements in the IVDR and MDR
    • The cybersecurity standards landscape
    • The new process lifecycle standard (81001-5-1)
    • The new technical report with product requirements (60601-4-5)
    • Introduction to FDA requirements and drafts
    • Introduction to ISO 27000
    • Summary

    Trainers

    Krishnadev Moothandassery Ramdevan
    Krishnadev Moothandassery Ramdevan
    Senior Quality and Regulatory Consultant
    Krishnadev holds a Master’s degree in Medical Engineering from KTH Royal Institute of Technology, Stockholm. He has a strong background in software development and testing within the pharmaceutical and life sciences industries, with over 10 years of professional experience. For the past five years, he has specialized in quality and regulatory assurance for medical device companies, helping organizations build and maintain compliant Quality Management Systems (QMS) with a strong focus on secure and safe software development. He has extensive hands-on experience working in compliance with EU MDR, ISO 13485, IEC 62304, IEC 81010-5-1, and ISO 14971.

    Target group

    Regulatory affairs managers, quality managers, development managers and senior software developers and IT managers who need to create a structured system for cybersecurity product risk management. A prior basic knowledge of risk management according to ISO 14971 and IT security is recommended.

    Objectives

    After the course, participants will have a general understanding of cybersecurity risk management with regards to development process, product and organization according to the latest international standards and of the requirements in European regulations, such as the IVDR and MDR. Participants will also understand where the ISO 27000 standards fit in.

    Additional information

    The course costs 8 600 SEK (excluding local VAT). The course is held in English.

    Cancellations must always be communicated to academy@aurevia.com and confirmed by us. Cancellations made more than 4 weeks before the starting date are free of charge. Cancellations made 2-4 weeks before the starting date of the event will be refunded by 50%. Cancellations made less than 2 weeks before the starting date of an event will not be refunded. If you are unable to attend, substitution with a colleague is possible and recommended. Aurevia reserves the right to cancel the course due to low attendance, up until 2 weeks before the course start. You can contact us at any time to get a status update. If the course is cancelled, a full course fee refund will be offered, but no additional reimbursements. We reserve the right to change the agenda, time and location, up until 2 weeks before the course. Aurevia reserves the right to change teachers or reschedule the course due to force majeure or due to teacher’s illness. No compensation will be paid for any additional costs incurred.

    Related courses

    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.