Quality...where it matters most
ShoeBar Associates focuses on services related to software application and development for companies in the FDA regulated area (medical devices and diagnostics, biotechnology, pharmaceutical, and vendors to any of these).
Agile Methods for Safety-Critical Systems: A Primer Using Medical Device Examples
This book, packed with real-world insights and direct experiences, is for managers who want the benefits of Agile but also must address regulatory compliance, integration of software with other disciplines, and product safety. In it, we combine our understanding of Agile development, hardware/software integration, and regulatory requirements. We know that Agile is simple but not easy; leadership is crucial to make this change spread. We aim to show how you can navigate the transition.
For more information click here. To order, go to the Amazon page.
Q&A - Adopting Agile for Medical Device Development
This white paper collects the most frequently asked questions we receive from medical device companies interested in knowing how Agile methods support modern high-assurance product development.
For a copy of this paper, visit our Presentations and Publications page.
Why ShoeBar Associates?
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Free White Paper - Guide for Software SOPs
Are you working to create a compliant quality system for your software development work, but unsure what topics to cover or what to incorporate in each procedure?
ShoeBar Associates has developed and refined these procedures many times, and has distilled that knowledge into a set of thoughts and questions to help you generate the SOPs you need.
To obtain a copy of this no-cost resource, email our administrator address (click link to email).
Agile Adoption for Regulated Medical Software: Business and Regulatory Impacts
This one-day introductory course, intended for managers, quality, regulatory, and other roles besides software development, presents the information you need in order to plan your transition to an Agile approach. Whether you are brand new to Agile, or have tried Agile and found your approach isn’t giving the hoped-for results, this course will fill in what you need to know.
Complete description here.