Agile Quality Systems combines the practicality of Agile Software Development and the discipline of Quality Management Systems into services that help medical device development organizations improve their performance, compliance, and team health.
Regulations and standards govern medical device development. While compliance is required, what matters more is the guidance that regulations and standards provide for product developers, helping them to develop safe and effective products. Agile Quality Systems knows how to apply the rigor and discipline of process in practical ways that help development teams focus their energy on creating robust designs.
Agile Software Development has been improving productivity, predictability, and quality for software teams for two decades. Medical device companies have been slow to adopt Agile, having concerns about its suitability for the safety-critical, regulated world of medical device software. The Association for the Advancement of Medical Instrumentation (AAMI) addressed these concerns by publishing "AAMI TIR45:2012 Guidance on the use of AGILE practices in the development of medical device software." As one of the lead authors of TIR45 and lead instructor for the associated AAMI course, Agile Quality Systems knows how to apply Agile Software Development in the medical device software domain, getting the advantages of Agile while meeting regulatory expectations.