August 28, 2018 in Cleveland, Ohio, BioOhio is once again teaming up with industry experts to bring a program focused on regulatory issues pertinent to Ohio’s medical device industry. This year’s event brings some of the medical device industry’s regulatory professionals directly to attendees. They will discuss changing regulations and present actionable recommendations for next steps, along with examining other critical industry trends. Exsurco is pleased to announce our Director of Regulatory Affairs and Corporate Compliance, Swasita Saigal, will be presenting at the forum on "Implementing then new EU MDR Post Market Surveillance (PMS) Requirements". She will discuss how new EU MDR identifies very specific requirements for the PMS system to be implemented throughout the entire product life-cycle, driving updates to the clinical evaluation, benefit-risk determination, design changes and customer information.
About Exsurco Medical®, Inc.
In 2015, Exsurco Medical moved into its own production facility, a standalone space with a Class 7 cleanroom for assembling and packaging in Wakeman, OH. Exsurco Medical also is registered with the FDA and is ISO 13485:2016 certified. Exsurco Medical’s mission is to advance incision science to improve the lives of patients in need of the healing power of skin. In 2017, the company launched a new wound debridement and skin grafting medical device, the Amalgatome SD® for use in burn and trauma centers. The product is currently in use in burn centers across the United States.