Unfortunately, reportable events (incidents) happen. When they do, your company must recognize them quickly and file the appropriate report(s) to the applicable regulatory agency(ies) within the timeframe required by each regulation. These reports include Medical Device Reports to the FDA, Medical Device Vigilance Incident Reports to the National Competent Authority in Europe, Mandatory Problem Reports to Health Canada, Incident Report Investigation Scheme to the Therapeutic Goods Administration in Australia, etc. Regulatory Insight can assist your company to determine if a reportable event occurred, and if so, how to meet all applicable reportable requirements. Unfortunately, recalls also happen. Certain regulations dictated by global regulatory bodies define the steps a company must take if the company determines that a recall is necessary or if a particular regulatory body requires a company to perform a recall. Regulatory Insight has handled many recalls for various clients in markets throughout the world. We know what is required by each regulatory body and we can assist your company not only with meeting the reporting and other regulatory requirements in every regulated market, but we can also assure that the recall is performed efficiently, cost-effectively and in the least disruptive manner to your company, and most importantly, to your customers.