Rules Are Changing for FDA Submissions for Software
Big news! After 16 years the FDA is changing its guidance on the software documentation needed in regulatory submissions.
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Newsletter V. 2021 Issue 2
September 2021 Newsletter – Digital Health and Medical Device Software Digital Health encompasses a broad range of products leveraging the latest software and communication technologies to improve patient health and increase the efficiency of healthcare systems. Some of the most innovative are software-only products (SaMD) utilizing sophisticated algorithms to analyze health data and aid clinicians
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Documentation for Medical Device Software
The documentation needed for medical device software is lengthy and complex. This article provides a list of needed documentation and tips on the best way to manage it.
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Accelerating Value Delivery for Medical Device Software
Erik Heuer describes his experiences accelerating medical device software development by bridging the gap between regulatory compliance and modern software development methods: incorporating DevOps concepts, leveraging documentation automation, and establishing the two wheels for innovation vs. development and deployment.
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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.
Newsletter V. 2021 Issue 1
April 2021 Newsletter – Better Approach to Medical Device Development Let’s Get Back to Basics Medical device development is often discussed in terms of adhering to new regulations or standards. While the complexities of good compliance are certainly important, it’s easy for teams to overlook the basics of what’s needed to successfully develop an innovative
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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
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.
Newsletter V. 2020 Issue 2
OCT 2020 Newsletter – Medical software challenges and new digital opportunities Some of the most promising innovations in healthcare technology today are based on software development and the digital health sector itself is a large and growing part of the industry (see below). Software enables many new opportunities in healthcare but also presents new challenges
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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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