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In 2012, the International Medical Device Regulators Forum (IMDRF) developed the Medical Device Single Audit ...
Amid the pandemic situation, and states’ officials struggling to secure Personal Protective Equipment, FDA ...
On Tuesday, March 31, 2020, the FDA announced a new program aimed at facilitating research and development of ...
Our Lead Quality Engineer, Nikita Angane, explains how to build a strong Quality Management System for your Software as a Medical Device.
Our Quality Engineer, Madison Wheeler, discusses the characteristics of an efficient product development process for medical devices and how medical device product development should incorporate Quality, Regulatory, and Business needs in parallel.
The European Medical Device Coordination Group published a joint implementation plan ahead of the May 2020 ...
As COVID-19 cases surge across the country, the health care industry is preparing itself to face ventilator ...
With the number of confirmed COVID-19 cases now exceeding 200,000 globally, the WHO and many other international ...
With the COVID-19 pandemic halting life as many know it globally, the May 26th EU MDR deadline still looms over ...
Earlier this month the ECRI Institute published its executive brief on this year’s Top 10 Patient Safety Concerns. ...
Amid the COVID 19 pandemic, with 10 states in the US declaring a ‘state of emergency’, foreign and international ...
May 2020 deadline for the EU MDR is fast approaching and the industry is scrambling to find the right resources ...
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