We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Citing the COVID-19 pandemic and other obstacles, the European Union has pushed back the dates by which manufacturers must comply with the EU’s IVD Medical Devices Regulation (IVDR). Read More
The European Commission has issued a regulation that will allow devicemakers to distribute instructions for use (IFUs) in electronic format, playing catch-up with the FDA and other international regulatory agencies that have already allowed devices to be accompanied by electronic-only instead of paper instructions. Read More
Allergan Aesthetics, an AbbVie company, has completed its $550 million acquisition of Irvine, Calif.-based Soliton, gaining that company’s rapid acoustic pulse device for improving the appearance of cellulite. Read More
Sponsors of devices already cleared through the FDA’s 510(k) pathway that wish to gain approval for changing the sterilization method they use may find it easier to do so under a new pilot program the agency is considering. Read More
Establishing a classification system for complaints helps organize your analysis. The customer is complaining the device is deficient in meeting one or more essential design output areas including: identity; quality; durability; reliability; safety; effectiveness; and performance. Read More