A report from the Association for the Advancement of Medical Instrumentation, namely, AAMI TIR 45, offers recommendations for how to comply with both international standards and guidance documents from the FDA when it comes to Agile practices for developing medical device software.
The AAMI TIR 45 is an attempt to align and synchronize Agile’s values, goals, principles and practices to medical device software development. It shows the ways of doing this. It seeks to remove the many misconceptions and myths surrounding the suitability and adaptability of Agile to medical device software and explains how to apply Agile methods for meeting the Quality System requirements set out for medical device software.
AAMI TIR 45 has been set out to help manufacturers of medical device software reap the benefits that Agile provides, while staying compliant with the regulatory expectations and requirements.
The AAMI TIR 45 was created because of the value that Agile can bring to medical device software. One of the reasons for which Agile was developed was to address concerns relating to the quality and efficiency present in the methods of software development that existed then. When its core features are adapted to the medical device software field, it brings enormous benefits, some of which include:
– It allows for continuous and persistent focus on risk management, safety and delivering customer value through its method of prioritizing backlog work, and practices relating to planning and customer feedback
– It uses continuous integration and testing to continuously and consistently assess quality
– Through its methods of retrospective action and accountability; Agile brings in continuous improvement into the process of software development
– By focusing on getting things done one stage at a time and thus ensuring timely and incremental completion of work and deliverables; Agile satisfies the demands and needs of the medical device company’s stakeholders in the management and quality areas.
A few reservations
Many experts in both medical device software and Agile fields have expressed reservations about the suitability that Agile has in an extremely stringently regulated area such as medical device software. They refer to the Agile Manifesto, which seems to contain value statements that seemingly contradict the values at the core of a Quality Management System.
They also draw attention to the fact that as Agile evolved at a time when there was no criticality attached to risk management and human safety; the controls needed for producing software to which safety is critical have not been embedded into Agile.
Requires proper understanding and implementation
These points notwithstanding; Agile comes with a fundamental adaptability to the context it is applied in. Implementing Agile principles and practices in a proper way makes it more than adequate in an area like medical device software, where safety is critical. It is perfectly well-suited to accomplishing the lifecycle steps prescribed in IEC 62304 and risk management under ISO 14971. It can also help achieve usability design as required under IEC 62366
A learning session on the AAMI TIR 45
Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer thorough clarity on the area of the suitability of the Agile to medical device software. The speaker at this session, Brian Shoemaker, will unravel the elements of AAMI TIR 45 and explain how it can be applied to medical device software smoothly and effectively in a manner that meets regulatory requirements.
Please visit Agile Meets Software Standards to register for this webinar and derive the benefit of understanding how to apply Agile principles to medical device software.
At this webinar, Brian will help understand how the AAMI TIR 45 can be the ideal roadmap for facilitating and bettering development, which benefits everyone concerned, be they development teams, companies, patients, caregivers, or regulators.
He will put this in perspective by explaining the following topics:
o Convergence: Agile principles and regulatory needs
o Lifecycle: incremental development, design reviews, documentation
o Key practices: planning, collective effort, product definition
o Implementation: evolving architecture, emergent design, continuous testing, traceability
o Managing your software: release, configuration management, third-party software, and CAPA
Brian will cover the following areas at this webinar:
o TIR 45 comes at a much-needed time
o TIR 45 stitches together the important high-level concepts
o TIR 45 outlines key practices that are needed for flexibility and quality
o Implementation issues are not ignored
o This TIR is actually just a starting point.
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