Newsletter V. 2023 Issue 1 – Announcing Sunstone Pilot’s Adaptive Design Controls
Announcing Sunstone Pilot’s Adaptive Design Controls- Embracing Change – equipping your product teams to handle these new challenges
Announcing Sunstone Pilot’s Adaptive Design Controls- Embracing Change – equipping your product teams to handle these new challenges
September 2022 Newsletter – Integrating Two Worlds of Product Development
September 2022 Newsletter – Integrating Two Worlds of Product Development
March 2022 Newsletter – Back to Basics with Design Controls. Changes are coming to design control regulations. Advanced design controls
December 2021 Newsletter – Digital Health – Big Updates from FDA
Big news! After 16 years the FDA is changing its guidance on the software documentation needed in regulatory submissions.
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 …
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 …
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. …
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 …