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A Simple Breakdown of ISO and IEC Standards for SaMD

Posted by Sierra Labs on Jul 3, 2023 11:04:00 AM

Understanding the difference and benefits between ISO and IEC Standards for Software as a Medical Device


In this day and age, software has become an integral part of medical device development. With the increased number of Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD), there are a number of regulatory frameworks that shape the development of these devices. In this blog, we will break down relevant ISO and IEC standards for SaMD startups developing innovations for the Healthcare space.

Achieving Compliance with International Frameworks

On medical device companies, road to compliance there are several international standards that they must take note of. There are currently two international organizations that decide and maintain standards and best practices for SaMD development, International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC).

Due to the increased complexity of software within medical devices, a more stringent regulatory review by regulatory bodies like the FDA has prolonged time-to-markets. Luckily, this same complexity has paved a path for organizations like the FDA to adopt ISO and IEC standards that allowing medical device companies achieve conformance and establish proper protection protocols for the safety of end-users.

For further clarification between Medical Device Software vs. Software as a Medical Device, check out Medical Device Software & SaMDs: A Crash Course!

Further Understanding of ISO and IEC Standards for SaMD

Many medical device manufacturers expose themselves to weaknesses and vulnerabilities by not aligning their processes to ISO and IEC standards.This results in a backlog for development and more importantly, a longer time-to-market. The first general standards that your software development teams should be familiar with when developing SaMD are explained in the following image.


Before any SaMD team can begin developing their medical device solution, they must have a strong understanding of what and who in their team should know both these ISO standards:

ISO Standard Description Who Should Know?
ISO 13485:2016 Defines what requirements medical device companies must adhere to with their QMS. It is designed to respond to the latest QMS practices, including changes in technology and regulatory requirements and expectations.  Quality Team
ISO 14971:2019 Defines a standard process for identifying risks associated with medical devices at all stages in a device’s life cycle, from product design to procurement to production and post-market use. Quality Team


Check out our blog on ISO 13845 vs 21 CFR 82, a comparative study on the key differences between FDA’s QSR and ISO’s QMS.

When it comes to meeting IEC standards, it is important to have a quality manager that can distinguish key regulatory terminology.

IEC Standard Description Who Should Know?
IEC 62304 Specifies life cycle requirements for the development of medical software and can be used as a key benchmark for compliance within both US and European markets. Software Project Manager(s) & Development Team
IEC 62366  Describes the various activities such as validation testing for interface design that should be implemented in a usability engineering process during SaMD development. Software Project Manager(s) & Development Team
IEC 60601-1:2 Ensures safety and effectiveness of device network, software interfaces and electrical equipment (hardware) through a series of technical standards. Software Project Manager(s) & Development Team

Equip Your Team with a QMS

Now that you have a clearer understanding of ISO and IEC standards, let’s talk about ways to actually meet conformance for these standards within your organization!

Having a QMS for SaMD startups is crucial for teams to stay on track and record the development of their device from start to finish streamlining demonstration of procedures and standards like ISO and IEC. Additionally, an SaMD QMS makes FDA audits a breeze by easily demonstrating full lifecycle traceability of your products.

Sierra QMS is designed for organizations who are looking to market SaMDs in a global regulated environment. Sierra Quality Management System (QMS) allows you to easily integrate risk management into your production process and operate with your own preferred tool-sets.

Want to see how implementing Sierra QMS will help you achieve ISO and IEC Certifications?

Click Here for a Free Demo!

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Topics: Agile, FDA, QMS, SaMD, Medical Device, risk, ISO 13485, ISO 13485:2016, ISO 14971, IEC 62304, SaMD Development, IEC 62366 , IEC 60601, IEC 60601:1, software as medical device, International Electrotechnical Commission, International Organization for Standardization

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