Systems Engineering in Healthcare: 2018 INCOSE Conference
19-20 April 2018 Minneapolis MN
Medical Software Development Essentials
23 January 2018
Developing software in compliance with the FDA Design Control regulations and international standards is challenging.
This one-day course provides background and suggestions for developing software in a manner that meets applicable FDA guidance documents and international standards, such as IEC 62304.
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 more than a decade. 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.