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

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

Sunstone Pilot NewsletterHeader

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 »