Your Medical Innovations, the FDA and Regulatory StrategyAs you strive to speed your innovations to the medical marketplace, it can feel challenging to explore development while also balancing US Food and Drug Administration (FDA) regulations. The good news is, it’s clear to see the FDA both wants to support industry innovations and advance discovery as
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
In June, the European Commission released Revision 4 of MEDDEV 2.7/1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies, found amidst other guidance documents here. The release constitutes a major re-write of the previously issued guidance (found here), increasing the document from 46 to 65 pages of "how-to" conduct the Clinical Evaluation. Though not legally binding
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
In Fine Point Consulting's continuing series on Leaders & Influencers, they spoke with Robin Martin, Chief Regulatory Strategist, and Jana Gerken, Chief Legal Strategist, co-founders of the newly formed Kinetic Compliance Solutions, which provides regulatory and legal services to emerging and mature companies specializing in the medical device and life sciences industries. Here is a portion of
Kinetic Compliance Solutions was proud to be represented as part of a recent panel discussion on women in entrepreneurship at the 2016 Wisconsin Entrepreneurs' Conference organized by the Wisconsin Technology Council. Erik Lorenzsonn of The Capital Times covered the panel and discussion. Read the full article here.
Kinetic Compliance SolutionsTM is a proud sponsor of the 2016 Governor’s Business Plan Contest and a participant on the “Lessons learned: Success stories from women entrepreneurs” panel at the 14th annual Entrepreneurs’ Conference on June 7-8th in Madison, Wisconsin. Click here for more info.
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
