Author: Kris Kelly

October 29, 2021

Why Outsourcing for Medical Device Software Development Makes Sense

One of the key success factors for medical device companies in the past 18 months has been developing trusted Partnerships for their Medical Device Software Development. When CEO’s need to hit their corporate goals,...

Podcasts

October 7, 2021

Burnout Crisis for Women in Med Tech

STEM job growth has been hot but the pandemic and return to work has brought about an exodus that threatens the strong progress that was being made over the past couple of decades to...

News & Blog

October 4, 2021

Why Privacy and Security are Essential in SaMD

Digital health technologies such as wearables, connected medical devices, and Software as a Medical Device (SaMD) are massively transforming healthcare. Significant innovations in IoT sensors, smart devices, and other small communication devices are driving...

News & Blog

August 9, 2021

SaMD – Software as a Medical Device is a Game Changer

SaMD – THE POWER TO DIAGNOSE, TREAT AND HEAL USING SOFTWARE AS A MEDICAL DEVICE Author: Timothy Reynal SaMD: SOFTWARE AS A MEDICAL DEVICE Software as a medical device, or SaMD, is a fast-emerging...

News & Blog

July 3, 2021

To CAPA or not to CAPA? That is the question…

CAPA – Corrective and Preventive Action Within the medical device industry, if not carefully administered and messaged properly within the company, Corrective and Preventive Actions are often perceived by employees as “black eyes” on company performance....