ISO 13485, Medical devices–Quality management systems–Requirements for regulatory purposes, is a global standard that establishes requirements for a quality management system. Take this test to see how well you know the basics. We’ll post the results in a couple of weeks. Good luck!
Jordi labs and its team of Ph.D. analytical chemists developed a proprietary, multi-detector approach to ensure that all extractables are accurately characterized to comply with global materials testing regulatory requirements.
On May 16-17, device developers, regulatory affairs and regulatory intelligence professionals will come together in Washington, DC, for two days of education, discussion and networking to share strategies and best practices on navigating current and on the horizon regulatory requirements.
The FDA is seeking input from organizations interested in collaborating with the agency on the development and execution of the medical device active surveillance system, which is focused around achieving better data capture and detection of potential safety signals in…
The MedTech Intelligence staff consists of freelance journalists and industry contributing writers with decades of experience in covering medical device issues under the categories of business, market trends, product development, quality, regulatory, and operations.
You can contact our writing staff via our Contact Page.