Agile Quality Systems

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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.

Agile Software Development has been improving productivity, predictability, and quality for software teams for two decades. While medical device companies were initially slow to adopt Agile, many of the initial concerns have been addressed, partly through the guidance from the Association for the Advancement of Medical Instrumentation (AAMI) published in "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 courses, Agile Quality Systems knows how to apply Agile Software Development in the medical device software domain, getting the advantages of Agility while meeting regulatory expectations.

As an experienced educator, Agile Quality Systems can provide training in the foundational principles of Agility, and in the mechanism of Agile Framework, including Scrum, Extreme Programming, and Kanban. As a SAFe(r) Program Consultant, Agile Quality Systems can provide training on the Scaled Agile Framework.

Moving beyond training to where the real learning happens, Agile Quality Systems coaches team in the practical application of Agile principles and practices, taking a pragmatic approach that helps organizations apply Agile within the unique constraints of the organizational context. 

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 Quality Systems has been connected to the INCOSE Healthcare Working Group since 2015, delivering presentations and webinars related to the application of Agile methods within a Systems Engineering framework, and coordinating the annual INCOSE HWG Systems Engineering in Healthcare conferences.

Agile Quality Systems is partnering with BeanStock Ventures to present:


Software Online Agile Regulatory Fundamentals Training for today's medical software engineer.   This is a 16 course training program that has been designed to maintain the team's agility while:

  • Aligning quality and software to efficiently integrate Agile into the regulatory landscape
  • Advancing regulatory knowledge for real world application
  • Establishing regulatory background and review requirements
  • Creating confidence in meeting aggressive product launches
  • Increasing ease in passing internal and external audits and inspections

For more information and registration, see the BeanStock Ventures site here.

Browse our services or contact us to see how Agile Quality Systems can help your organization.