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 […]
What Are Medical Device Design Controls? Read More »
Wishing you all the best during this Holiday season and a prosperous New Year. Aaron Joseph Streamlined Compliance for Medical Device Development Sunstone Pilot, Inc. sunstonepilot.com
Happy Holidays 2021 Read More »
December 2021 Newsletter – Digital Health – Big Updates from FDA
Newsletter V. 2021 Issue 3 Read More »
Big news! After 16 years the FDA is changing its guidance on the software documentation needed in regulatory submissions.
Rules Are Changing for FDA Submissions for Software Read More »
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
Newsletter V. 2021 Issue 2 Read More »
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.
Documentation for Medical Device Software Read More »
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.
Accelerating Value Delivery for Medical Device Software Read More »
A post-mortem or retrospective is a valuable opportunity to make long-term improvements in a product development organization. Understanding the goals of a post-mortem and avoiding the 4 common pitfalls will ensure a successful and valuable outcome of the post-mortem.
Post-Mortem Pre-Celebration Read More »
Product teams that skip Phase Zero and jump straight into development appear to be on a faster path to market. But the consequences of a lack of Phase Zero will become painfully apparent late in product development, when problems are much more expensive to fix.
Successful Product Development: A Tale of Two Companies Read More »
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.
