News

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

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

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

The world as we know it is changing. Covid-19 has created huge disruptions and it’s harder than ever for teams to effectively communicate and develop new medical devices. Business collaboration and decision making are increasingly difficult. Fortunately plenty of organizations and companies are broadcasting new tools for collaboration. Maybe you’ve seen ads on LinkedIn for