AAMI TIR45: Definition, Compliance, Tools, and Certifications

Introduction

Agile has been part of the software development industry for almost two decades. It’s been quite common in non-regulated sectors like e-commerce, retail, and others, but the medical device sector has been wary of it. AAMI TIR45 is a technical information report that offers the proper recommendations for developing Software as a Medical Device (SaMD). This report is well-aligned with FDA guidance documents and even international standards like the EMA. If you are developing a SaMD, it’s important to be familiar with AAMI TIR45. In this article, we will take a closer look at what AAMI TIR45 covers.

What is AAMI TIR45?

AAMI TIR45 is a guidance document that covers the development, validation, and risk management of SaMD. AAMI TIR45 is based on the IEC 62304 standard for software used in medical devices. The AAMI TIR45 guidance was created by a working group of experts from around the world, including representatives from device manufacturers, academia, and regulators.

The AAMI TIR45 gives concise directions for applying Agile in the development of medical device software. Developers also had more confidence to implement this approach because of a few additional elements:

• Agile has grown in popularity among businesses across many industries.
• The more organizations adopted it, the more Agile processes evolved and it became clear that the technique does not violate medical software development regulations.
• Finally, the FDA has given Agile approaches its seal of approval.

What Does AAMI TIR45 Cover?

AAMI TIR45 covers the development process of SaMD from start to finish. This includes requirements for design inputs, software development activities, and design outputs. The standard also includes recommendations for validating SaMD before it is released to the market. In addition, TIR45 provides guidance on risk management throughout the development process.

The Agile In-Transit Insurance Replacement (AAMI TIR45) was created to demonstrate how to safely apply the Agile framework in the field of medical device creation. It is, therefore, focused on addressing important misunderstandings about adopting Agile software development processes in MedTech, such as:

• The Agile approach is not highly regulated, with strict procedures and documentation in place to comply with.
• The Agile approach hasn’t had enough time to establish itself as a safe, effective, and reliable technique for developing safety-critical items.
• Even if Agile was appropriate for MedTech software development, the FDA would insist on waterfall processes due to the inherent conflict between “rapid time-to-market” and “good system design.”

The TIR45 also highlights the following Agile and MedTech development measures to assure synchronization:

1. Lifecycle modeling is strongly advised for complex development processes to be performed in a structured and disciplined manner.
2. Documentation that is adequate if not over-the-top (naturally, this is always advised for ensuring quality and compliance, but it’s worth repeating)
3. The processes implemented must be consistent with the company’s Quality Management System.
4. Meticulous change management is necessary for effective quality control and risk management.

Why is AAMI TIR45 Important?

AAMI TIR45 is important because it provides a comprehensive guide to developing SaMD that is compliant with international standards. TIR45 can help you avoid potential pitfalls in the development process and ensure that your SaMD meets all the necessary requirements for safety and efficacy.

And how is agile beneficial for the medical device industry?

Agile processes may provide significant value to the developers of medical device software. In traditional medical software development processes, the cost of correcting an error increases as you go deeper into the product lifecycle, and it’s more expensive as you get closer to the release date. As stages become more rigid and follow one after another, the expense of making a change goes up because delaying it is inherent in this conventional approach.

• Agile processes are iterative, which means that they can be easily adjusted to accommodate changes in requirements.
• Agile processes promote collaboration between stakeholders and developers.
• Agile processes can help reduce the risk of defects in SaMD by allowing for early detection and correction.

Tools and Certifications Mentioned in AAMI TIR45

There are several tools and certifications mentioned in AAMI TIR45 that are required by the FDA for SaMD. These include:

• IEC 62304 Certification: This certification is required for all software used in medical devices. IEC 62304 is an international standard that covers the development, validation, and risk management of software used in medical devices.
• ISO 13485 Certification: This certification is required for all medical device manufacturers. ISO 13485 is an international standard that covers quality management systems for medical device manufacturers.
• Risk Management File: A risk management file must be created for all medical devices. The risk management file should contain a risk analysis, risk mitigation plans, and post-market surveillance plans.
• Clinical Evaluation Report: A clinical evaluation report must be created for all medical devices that are used in humans. The clinical evaluation report should assess the safety and efficacy of the device.

How Can I Use AAMI TIR45?

If you are developing a SaMD, you should familiarize yourself with AAMI TIR45. It can be used as a resource during the development process to ensure compliance with international standards. In addition, many of the tools and certifications mentioned in AAMI TIR45 are required by the FDA for SaMD.

Visure Requirements ALM Platform for AAMI TIR45:

Visure requirements ALM platform is a comprehensive and collaborative platform that includes full traceability, tight integration with MS Word/Excel, risk management, test management, bug tracking, requirements testing, requirements quality analysis, requirement versioning and baselining, powerful reporting, and standard compliance templates for IEC-62304, FDA 21 CFR Part 820 and Part 11, AAMI TIR45, and ISO-14971.

Visure is a highly trusted requirements management tool in the medical device industry. The company integrates through the whole ALM processes including risk management, issue and defect tracking, traceability management, change management, and various other areas like quality analysis, requirements versioning, and powerful reporting. Some of the top Visure clients include Glaxo Smith Kline (GSK). Randox Health, NeuroElectrics, HealthNet, etc.

Conclusion

AAMI TIR45 is a comprehensive guidance document for developing SaMD. It covers the development process from start to finish, including requirements for design inputs, software development activities, and design outputs. The standard also includes recommendations for validating SaMD before it is released to the market. In addition, TIR45 provides guidance on risk management throughout the development process. If you are developing a SaMD, you should familiarize yourself with AAMI TIR45. It can be used as a resource during the development process to ensure compliance with international standards. In addition, many of the tools and certifications mentioned in the standard are required by the FDA for SaMD. Visure Requirements ALM Platform helps you comply with AAMI TIR45 with ease. Request a free 30-day trial at Visure Requirements ALM Platform to see how our tool can help your projects run more smoothly.