normed

ISO/TS 24971-2 Published: Practical Guidance on Applying ISO 14971 to Machine Learning Medical Devices

Wed, 08 Jul 2026 20:57:32 GMT

ISO/TS 24971-2 has now been published, providing practical guidance on applying ISO 14971 to machine learning-enabled medical devices. As a member of the ISO/IEC Joint Working Group responsible for developing the specification, I wanted to share the key takeaways and what they mean for manufacturers developing AI-enabled Medical Device Software (MDSW)

A new milestone for AI-enabled medical devices

One question that has become increasingly relevant over the last few years is how ISO 14971 should be applied to machine learning-enabled medical devices.

With the publication of ISO/TS 24971-2, manufacturers now have dedicated technical guidance describing how the principles of ISO 14971 can be applied throughout the lifecycle of ML-enabled medical devices.

As members of the ISO working group responsible for developing the specification, we at NorMed Consulting are pleased to see the publication of this important document.

Why this matters

Machine learning introduces considerations that extend beyond traditional software development.

Manufacturers must consider topics such as:

dataset quality and representativeness
algorithm training and validation
model updates and change management
performance monitoring
bias and generalizability
human oversight
post-market performance monitoring

ISO/TS 24971-2 provides practical guidance for incorporating these aspects into an ISO 14971 compliant risk management process.

Who should read it?

This publication is particularly relevant for:

AI/ML Software as a Medical Device (SaMD)
Clinical Decision Support Software
Digital Therapeutics
Imaging AI
Predictive analytics
Connected medical software

It will also be valuable for regulatory, quality, software, clinical and risk management professionals working with AI-enabled medical devices.

Practical implications for manufacturers

Many startups developing AI-enabled medical devices face similar questions:

How should AI-specific hazards be identified?
How should training data be documented?
How should performance degradation be monitored?
How should model updates be managed?
How should verification and validation be adapted for machine learning?

ISO/TS 24971-2 provides practical guidance that complements ISO 14971 by addressing these questions within an established risk management framework.

How NorMed Consulting can help

Developing AI-enabled medical devices requires more than software expertise. Manufacturers must demonstrate that AI-related risks have been systematically identified, evaluated, controlled and monitored throughout the product lifecycle while satisfying regulatory expectations under the EU MDR and FDA frameworks.

At NorMed Consulting, we support startups and established manufacturers with:

AI/ML regulatory strategy
ISO 14971 risk management
Clinical Evaluation (ISO 18969)
Software lifecycle processes (IEC 62304)
Usability Engin eering (IEC 62366-1)
FDA regulatory submissions
EU MDR Technical Documentation
Quality Management Systems (ISO 13485)

Having contributed directly to the development of ISO/TS 24971-2, we are well positioned to help manufacturers interpret and apply the guidance in a practical and proportionate manner.

Looking ahead

The publication of ISO/TS 24971-2 represents another important milestone in the continued evolution of risk management for modern medical devices.

Work is already progressing on ISO/TS 24971-3, addressing combination products, while revisions to ISO/TR 24971-1 are expected to further strengthen guidance on the practical application of ISO 14971.

Need support?

Whether you are an early-stage startup developing your first AI-enabled medical device or an established manufacturer expanding an existing portfolio, NorMed Consulting can help navigate the regulatory, clinical and risk management challenges associated with AI/ML medical technologies.

Set up a free scoping meeting today!

�� Further information and sources:

ISO/TR 24971-1: https://www.iso.org/standard/74437.html
ISO/TS 24971-2: https://www.iso.org/standard/24971-2
I SO/TS 24971-3: https://www.iso.org/standard/91186.html

🌐 Understanding Standards 🌐

Thu, 20 Jun 2024 17:56:43 GMT

What is the difference between a 'TR', 'TS', 'IS' and 'EN? ��

As a member of ISO and IEC, I often encounter questions about the differences between an International Standard (IS), Technical Report (TR), Technical Specification (TS), and European Standard (EN). Understanding the difference between these types of documents and their compliance levels is crucial for medical device manufacturers and often misunderstood, both by newcomers to the industry, as well as seasoned regulatory affairs professionals. Here’s a quick guide:

�� Technical Report (TR)
TR documents, such as ISO/TR 24971 , provide guidance and information rather than mandatory requirements. They are designed to support manufacturers in understanding and implementing best practices related to, for example, risk management, usability engineering, and other aspects of medical device development. While not compulsory, adhering to the recommendations in a TR can enhance the robustness of a manufacturer’s processes and align them with industry expectations, potentially facilitating regulatory approval.

�� Technical Specification (TS)
A TS provides requirements and recommendations based on the latest technical advancements and market needs. It’s a more flexible document compared to an IS and can be used when there is a need for a fast-track solution or when the subject matter is still under development. TS serves as a stepping stone towards a full International Standard, allowing industry feedback and refinement.

�� International Standard (IS)
IS documents, such as ISO 13485 for quality management systems in the medical device industry, are formal requirements that must be implemented to achieve compliance. These standards are often mandated by regulatory bodies and need to be integrated into a company’s Quality Management System (QMS) and product development processes. Compliance with these standards ensures that products meet safety, efficacy, and regulatory requirements.

�� European Standard (EN)
An EN is a standard developed by CEN (European Committee for Standardization) or CENELEC (European Committee for Electrotechnical Standardization) that applies across Europe. While not inherently legally mandatory, EN standards often become de facto mandatory when referenced by European regulations or directives, facilitating trade and ensuring safety and interoperability within the European Single Market.

�� Being a visual learner but terrible at drawing, I tried to depict this relationship in the diagram provided above.

�� Sources :

ISO Standards
IEC Standards
EN Standards

Update on ISO/IEC Standards in MedTech

Thu, 20 Jun 2024 16:57:16 GMT

This is a subtitle for your new post

Amidst the wave of standards in the AI domain and the intense focus on AI regulation, key developments specific to the MedTech sector may have slipped under the radar.

Here are is a distilled overview of five work items in the domain of medical devices that warrant your attention! ��

�� IEC 62304: This cornerstone standard for Medical Device Software (MDSW) has been approved for revision by a newly formed IEC Maintenance Group (MT). Considered long-overdue by some, this should be on the radar of anyone working with MDSW.

�� ISO/TS 24971-2: Offering guidance on the application of Risk Management (i.e., ISO 14971) to AI-enabled medical devices, this new Technical Specification (TS) is based on previous guidance developed in collaboration between AAMI and BSI and is developed in a Joint Working Group (JWG) between ISO and IEC.

�� IEC/TS 62366-2: Recognized as a guidance in the application of Usability Engineering to Medical Devices, this document—presently a Technical Report (TR)—was recently approved for revision which includes the conversion into a Technical Specification (TS).

�� ISO/AWI 18969: Currently being developed in a Working Group (WG) under ISO, this standard is aimed to be the first covering the highly complex domain of Clinical Evaluation within the MedTech industry, making it one of the more anticipated work items on the list.

�� ISO/IEC AWI TR 18988: The scope of this new Technical Report (TR) includes the identification of processes, factors, concepts, and terms related to AI in health informatics.

The prevalent use of abbreviations in standardisation may serve expert members but can make the work surrounding standardization seem like a 'black box' to people outside the committees. If this post has sparked your curiosity, you might wonder:

��What is the difference between a Technical Specification (TS), Technical Report (TR) and a International Standard (IS) and how does it affect compliance?
��Where is this work undertaken and how does one get involved?
��What is the difference between a Maintenance Group (MT), Joint Working Group (JWG) a regular Working Group (WG)?

In a hope to lessen the ambiguity surrounding this work and promote broader understanding, I plan to address these questions and others in upcoming posts - some of which will be in collaboration with Danish Standard and other industry stakeholders. I hope to see you contribute in the comments and join the forthcoming discussions! ��️