Intro to SaMD

SaMD, or Software as a Medical Device, is not just another mobile app.  It is a new category of medical device that has particular regulatory considerations and is at the forefront of some of the most innovative new healthcare technology.

Get a Grip on Medical Device Development

Or the 5 Types of Knowledge needed for successful Medical Device development Developing innovative new products is hard but developing innovative new medical devices is even harder. That’s because while both involve a great deal of knowledge, medical device development requires even more knowledge and across a broader range of domains.   Some engineers assume …

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Goodbye 2020 - year of storms

Goodbye 2020

As we come to the end of 2020, a year that can only be described as stormy, we wanted to send you a quick note of appreciation.  We are grateful for our connection and the opportunity to work together. Thank you for your support, your business, and your resilience in the face of uncertain–often tumultuous–times. …

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software testing

Software Testing Is Not Hardware Testing

Best practices for medical device HW testing are not best for SW testing Medical device development teams often ask me for help with software V&V. Even though they have their hardware development under control, these teams keep encountering software testing problems and the corresponding compliance documentation.  Frequently, it’s because their company’s quality system, explicitly or …

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