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Just like every other nation, Australia has also taken several measures to respond to the global pandemic. To help ...
The COVID-19 pandemic has caused mass shortages of ventilators and PPE globally, but now healthcare workers are ...
In our last blog on COVID-19’s impact on the EU MDR, the commission had not yet laid out any intentions of moving ...
Canada has been facing the same difficulties as many other nations due to the novel coronavirus. In light of the ...
Are you a manufacturer and want to help with the COVID-19 Pandemic? We invite you to attend our upcoming webinar to learn more about FDA’s temporary policies for regulating Personal Protective Equipment (PPE), Reprocessing, Ventilators and Hand Sanitizer manufacturing, and what you need to do to get your product on the market.
Health care facilities are facing shortages of medical equipment, drugs, PPEs and essentials such as hand ...
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 ...
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