Tracability in Medical Device

One of the critical aspects of SaMD/SiMD development is traceability. This concept is the key to success for FDA or MDR compliance as well as in the field. The main point here is to make sure each feature or test case can be traced back to the corresponding product requirement and the changes introduced in the product. Unfortunately, these simple traceability requirements are very easy to mess around with.

To avoid such situations, it is better to mark requirements with tags or other unique identifiers right from the project start. This way teams can trace their tasks and relevant changes right to the project requirements and cross-link them with corresponding tasks of other teams. The bottom-to-top requirement traceability allows for faster FDA or MDR approval.

The above situations create a huge confusion about whether a SaMD/SiMD project should be managed in the agile, waterfall, or V model. At a very first glance, it looks very tempting to manage such projects with the V or waterfall model . Well, it works for those projects where project scopes are very well known, risks are very high and the cost of non-conformity or failure is extremely high. But the rigidity of such a process may not be optimal for small organizations or where the product requirements are still in the exploratory phase. One thing must be noted that ISO 13485 or IEC 62304 does not dictate specific methods for SaMD or SiMD project management. Rather these standards expect a pre-defined and approved way of developing the product where bottom-to-top traceability can be documented and demonstrated. Therefore, we can of course use agile methodology as well to manage SaMD/SiMD projects.

The challenge when adopting agile methodologies during the development of SaMD/SiMD is to maintain the necessary documentation and traceability to demonstrate regulatory compliance. Furthermore, the lack of up-front planning and managing multiple releases also create challenges that are not primarily challenges in V or the waterfall model.

While Agile methods have their fair share of challenges in their implementation in the Medical Device Industry, the Association for the Advancement of Medical Instrumentation published a Technical Information Report on “Guidance On The Use Of AGILE Practices In The Development Of Medical Device Software”

It focuses on the following areas.

a. provide motivation for the use of AGILE

b. clarify misconceptions about the suitability of AGILE and

c. provide direction on the application of AGILE to meet quality system requirements.

However, the TIR report does give a solid hands-on approach to how software developers can pragmatically apply the Agile methods to develop SaMD/SiMD that complies with IEC 62304. In the next article, the focus would be on how we can practically apply agile methodologies in SaMD or SiMD development.

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