Aaron Joseph

What Are Medical Device Design Controls?

Medical device design controls are the regulations that govern the development of medical devices. The FDA established design controls in 1997 because they found that manufacturing controls alone were not sufficient. The FDA recognized that many patient injuries and deaths were the result of medical devices with fundamental design flaws (i.e. no matter how carefully …

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SaMD

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.

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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MDM 2020

Looking forward to presenting at MD&M with Roger Tang

The Two Mindsets of Successful Medical Device Development Modern product development teams face increasing challenges in bringing new medical devices to market: greater product complexity, tighter budgets, and more regulatory scrutiny. Agile and Lean practices, properly implemented, can enable medical device companies to accelerate product development, improve product quality, and lower manufacturing costs while still …

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