Introduction to Security Risk Management for SW96 and TIR57 Compliance
Master the essentials of security risk management for medical devices and health software. This course gives you practical tools to apply SW96 and TIR57, build robust threat models, and strengthen your organisation’s cybersecurity risk framework.
Purpose and Outcome
This specialized course provides practical guidance on achieving security risk management in compliance with AAMI/ANSI SW96 and TIR57/97. It also explores how to integrate or align these frameworks with other risk management systems, such as ISO 14971, and – if relevant to participants – AI security considerations.
Participants will learn how to identify the product and its intended market, analyze foreseeable security hazards and threats within the system, and how to use this threat landscape to conduct a structured security risk analysis, offering a systematic framework for identifying, controlling, and mitigating risks in medical devices / health software.
Upon completion of the course, you will be able to:
- Understand the key concept of building a risk-based threat model
- Construct a structured analytic approach to cyber security risk management
- Become familiar with the content of the SW96 and TIR57 standards, and develop a toolbox for implementing them effectively
- Strengthen and expand the cybersecurity framework component of risk management in your organization
Content
General Introduction to Polymer Materials
The course is based on a fictional case study or, preferably, real-world examples provided by participants. The trainer encourages dynamic, participant-driven discussions and examples. The training combines classroom presentations with interactive discussions, allowing participants to explore specific topics in greater depth based on their interests and needs.
The technical nature of threat modelling will be determined by the wanted technical expertise of the participants, but this is not a course solely focusing on threat modelling.
Who should attend
This training is designed for organizations that are either new to cybersecurity risk management or already engaged in cybersecurity activities but seeking new inspiration. The course is suitable for participants with beginner to intermediate knowledge of cybersecurity. It primarily focuses on cybersecurity processes with some coverage of technical activities.
The course is relevant for:
- Cybersecurity Quality Assurance / Quality Assurance Engineering
- Cybersecurity Regulatory Affairs
- Cybersecurity Product Responsible
- Cybersecurity System Engineer
- Cybersecurity Product Owner
- Cybersecurity Program Manager
- Security Champions in Development Department
- Cybersecurity Software Engineers
- Cybersecurity Test and Verification
Trainer
Jens Schønberg
CEO, Founder and Principal Cybersecurity Specialist, JBS Consultancy
Jens Schønberg specialises in product cybersecurity, security risk management and regulatory requirements for medical devices and health software. On this course, he guides participants through the practical application of ANSI/AAMI SW96 and TIR57, including threat intelligence, threat modelling, security risk analysis and risk mitigation. He also shows how cybersecurity risk management can be aligned with ISO 14971 and integrated into an organisation’s broader cybersecurity framework. As an editor of the upcoming ISO-led standard incorporating SW96 into the ISO framework, he brings direct insight into the evolving international requirements.
Contact
Select date
13 September 202713 September 2027 - at 09:00 - 16:30
Price ex. VATLatest Registration
6 September 2027
Latest Cancellation
15 August 2027
Bøge Allé 5, 2. th
2970 Hørsholm
Terms
In-house Courses
MedTech Academy offers in-house training courses tailored to your specific needs. Courses can be based on our open programme or developed specifically for your organisation. You choose the focus, format and timing – and work with your own cases in a confidential setting. Contact us to discuss the possibilities.
Do You Have a Specific Competency Need?
We continuously develop and update MedTech Academy’s course portfolio to match the current needs of medical device companies. If you are looking for a specific course, or if you are unsure which course is the right fit for you and your organisation, you are always welcome to contact us.
Berit Munkebo
Head of Development
bm@medicoindustrien.dk
Academy News
Academy News is Medicoindustrien’s weekly newsletter with a complete overview of upcoming and newly developed courses from MedTech Academy. The newsletter provides a quick overview of new dates, upcoming sessions and current course topics for professionals working with medical devices.