SIQ: Online workshop: Cybers security of Software in Healthcare and Medical Devices – the Role of the IEC 81001-5-1 Standard

This workshop will be in English and is part of our new academy cooperation with the Slowenian notified body SIQ!

Cyber threats in healthcare are rising. Are your medical devices secure?

As cyberattacks threaten patient data and disrupt care delivery, the importance of cybersecurity in medical devices is paramount. The Medical Device Regulations (MDR) 2017/745/EU and 2017/746/EU, along with the upcoming EU Cyber Resilience Act, underscore this responsibility for manufacturers like yourselves. Protecting sensitive patient data, patient safety and software from these evolving threats is crucial.

How to ensure the cybersecurity of a product?

The seminar covers managing cyber risks in medical devices throughout their lifecycle. Learn about key guidelines and a new standard that defines activities for each phase, from concept to maintenance, ensuring cybersecurity and resilience against cyberattacks. Following this framework helps manufacturers develop secure devices and protect patient data. The standard (IEC 81001-5-1) becomes mandatory under EU regulations by mid-2024.

Gain Expertise in Securing Medical Software and Devices

This course equips you with the knowledge and skills to navigate the critical landscape of cybersecurity for healthcare software and medical devices.

  • Understand the growing threats of cyberattacks on patient data and healthcare systems.
  • Learn best practices for secure software development and deployment in the medical field.
  • Address current challenges and emerging trends in medical device cybersecurity.
  • Master the IEC 81001-5-1 standard for identifying and managing security risks in medical software.
  • Implement security measures throughout the entire software development lifecycle, from planning to post-market maintenance.

This course empowers you to contribute to the development and management of secure medical software and devices, ultimately safeguarding patient safety and improving healthcare outcomes.

Deep Dive into IEC 81001-5-1 for Secure Medical Software

This comprehensive course explores the critical aspects of securing medical software and devices.

  • Demystify Regulatory Requirements: Gain a clear understanding of relevant regulations and standards, with a focus on IEC 81001-5-1.
  • Implement Security Throughout the Lifecycle: Learn how to integrate the IEC 81001-5-1 requirements seamlessly into each phase of your product development cycle, from initial concept to post-market support. This covers product specifications, architecture, development, testing, market release, and ongoing maintenance.
  • Master Threat Modeling: Explore the STRIDE methodology for effective threat modeling, allowing you to proactively identify and mitigate security risks in your medical software.
  • Quality Management Integration: Discover how to seamlessly integrate medical software management processes into your existing quality management system, ensuring consistent and controlled development practices.
  • Compliance Made Easy: Understand how to demonstrate compliance with the IEC 81001-5-1 standard and identify the required documentation to streamline the process.

By taking this course, you’ll gain the knowledge and skills to develop and manage secure medical software that prioritizes patient safety and adheres to the highest security standards.

Recommended for

  • Software developers and engineers
  • Healthcare IT professionals
  • Quality assurance specialists
  • Healthcare and medical software project managers
  • Healthcare and medical software manufacturers
  • Representatives or suppliers of medical software
  • Those responsible for the quality and compliance of medical devices
  • IT staff responsible for maintaining networks in which medical devices operate
  • IT network maintainers in healthcare facilities or in networks where medical devices operate
  • Risk managers

Costs

  • Standard: 475,00 EUR (excl. VAT)
  • Get your special 10 % en.co.tec-discount with this code: encosiq10
  • incl. seminar documents as PDF and a certificate of participation.

Your Trainer

Aljaž Podboršek has extensive knowledge in the field of medical devices, which he has acquired over the past 20 years. His expertise encompasses both the development of medical devices and the legislation that governs them. He has also gained experience in the establishment of various quality management systems. During his time at a medical device manufacturer, Aljaž successfully integrated quality management systems into the company’s operations. He also played an active role in the development, production, and compliance of medical devices with regulations and quality management systems in various markets. Currently, Aljaž holds the position of quality manager at a medical device manufacturer. He is also an auditor of quality management systems and technical files for medical devices at SIQ, a Slovenian company that provides certification and training services.

Location: ONLINE

The online workshop will take place in a live online e-classroom. Up to two days before the implementation, registered participants will receive a link to the online training. Participants need a computer with a microphone and a camera, as well as access to a reliably functioning internet connection to participate in online training without interruption.

Click here to book now!

Don’t forget to use this code for a special 10 % en.co.tec-discount: encosiq10

For questions please text: office@encotec.at or call +43 1 8863491

This workshop will be in English and is part of our new academy cooperation with the Slowenian notified body SIQ!