Quality ... where it matters mostShoeBar 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).
Coming this spring - Medical Device Courses!Two one-day courses to support and guide your transition to an Agile development approach. For information and downloadable course descriptions, visit our Agile Courses page.
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Why ShoeBar Associates?
MissionShoeBar Associates is committed to helping our clients establish software quality and control, to achieve regulatory compliance, world-class product reliability, and unquestioned patient and user safety.
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News and Upcoming EventsOur Services
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Complimentary White Papers
- Q&A - Adopting Agile for Medical Device Development
The most frequently asked questions we receive from medical device companies interested in knowing how Agile methods support modern high-assurance product development. - Guide for Software SOPs
A helpful set of questions and suggestions to help you generate the procedure documents you need.
Are you concerned whether your software processes will pass muster with the FDA or other regulators?
Do you need to validate software tools that your QA or software development groups use?
Do you wonder whether your approach to electronic records and signatures will fly with the regulators?
Do you need to conduct an internal quality audit of your software development, but don't have the resources?
If any of these, contact ShoeBar Associates for help!
Do you need to validate software tools that your QA or software development groups use?
Do you wonder whether your approach to electronic records and signatures will fly with the regulators?
Do you need to conduct an internal quality audit of your software development, but don't have the resources?
If any of these, contact ShoeBar Associates for help!