TECHNICAL BLOG SERIES – Quality Assurance Testing

MEDICAL DEVICE DEVELOPMENT USING AGILE PRINCIPLES

Read all about it!! Technical QA Blog Series Update!

Beginning in April 2020, we will begin publishing a blog series on performing Medical Device Development using Agile/Scrum  methodologies.  Many myths and misconceptions exist on this subject, and some folks believe that using Agile methods are completely incompatible with medical device development.  For example, the Agile Manifesto states that, “we value Individuals and Interactions over Processes and Tools.”  Designing and developing a medical device requires adherence to various standards and laws, so how can we ignore process?  Another example in the manifesto states, “we value working software over comprehensive documentation.”  Again, medical device development requires that we provide documentation to prove that we have followed processes and complied with standards and laws.  This blog series will explore the many aspects and conflicts involved in this development and will reveal the true compatibilities of the ideas and absolute advantages to adhering to Agile principles in product development of medical devices.

Stay tuned to learn more about this interesting topic!