Newsletter V. 2022 Issue 1
March 2022 Newsletter – Back to Basics with Design Controls. Changes are coming to design control regulations. Advanced design controls
Newsletter V. 2022 Issue 1 Read More »
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
What Are Medical Device Design Controls? Read More »
Happy Holidays 2021
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 »
Newsletter V. 2021 Issue 3
December 2021 Newsletter – Digital Health – Big Updates from FDA
Newsletter V. 2021 Issue 3 Read More »
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.
Rules Are Changing for FDA Submissions for Software Read More »
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
Newsletter V. 2021 Issue 2 Read More »
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.
Documentation for Medical Device Software Read More »
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.
Accelerating Value Delivery for Medical Device Software Read More »
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
Newsletter V. 2021 Issue 1 Read More »