Risk management is a vital planning step for any organization. Risk management involves identifying and minimizing potential risks for your company. It’s essentially the process of anticipating potential risks a company could face, and taking the necessary steps to reduce the possibility of them occurring. Risk management is important because it protects both your organization
After years of requiring most device manufacturers (besides IVD) to spell out the meaning of symbols within their labeling, FDA has issued a final rule that "allows the use of stand-alone symbols in medical devices without adjacent explanatory text". Previously, harmonized symbols recognized globally, such as "2" with a circle around it and slash through it
You’re in the process of developing technology, have established you’ve got a medical device on your hands, and know it will require FDA 510(k) clearance. Navigating this process is critical to your company’s and your technology’s success. Why? Unlike most industries, selling your “prototype” or “next-gen product” (anything prior to clearance) is not permitted and
Milwaukee Journal Sentinel author Tim Keane discusses the robust medical device and IT ventures that are locally-based in the Milwaukee area. Kinetic Compliance Solutions, LLC is one of those startups mentioned in Tim's article. Read the full article here.