April 2022

Full Spectrum is often engaged to assess software cybersecurity for our clients.  So, when the FDA issued its new draft guidance to the MedDevice industry (Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA - April 8. 2022) we expected the FDA to reinforce its stated policy to be ‘vigilant and responsive’ to the cyber-security issues related to medical devices.    However,...

Like most sectors of the US economy, the Covid pandemic has laid bare every existing product development challenge that the Medical Device industry has had for years. In March of 2020, when Covid cases started spiking and emergency orders closed offices and manufacturing plants across the country and around the globe, most executives didn’t focus on the impact on their product development efforts first.   The crisis...