Cognition’s latest ebook “Safety by Design: Guided compliance for risk reduction in medical device production and commercialization,” explores how to mitigate risk during the device developmental process. The ebook looks at pressing topics such as understanding the challenges that surround the meeting requirements of the FDA and other regulatory bodies, FDA’s position on risk reduction and automatic traceability. When submitting for regulatory approval, companies need to demonstrate that they have used a well-defined, documented design control and risk management process in place, along with evidence that they are following it. Cognition’s Cockpit Platform provides templates that are configurable to meet common standards and regulations.
To access the full ebook, click here.
