The Importance of Organizational Risk Management in the Medical Technology World

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

By | 2017-08-10T12:13:26+00:00 August 8th, 2017|Medical Device Information, Regulators|

FDA Modifies Medical Device Labeling Requirements

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

By | 2017-08-08T21:57:16+00:00 June 30th, 2016|Medical Device Information|

Breaking Down the 510(k) Process

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

By | 2017-08-08T21:57:26+00:00 May 19th, 2016|Medical Device Information|