This webinar will focus on the newly codified regulatory requirements for post-market surveillance (PMS) under the new Medical Device Regulations (MDR) set to go into enforcement in May 2020.
These new PMS requirements push the manufacturer to take a more active role in monitoring of their devices to ensure that the benefit-risk profile of the device remains current.
Performing PMS activities, according to the risk class of the device, requires a cross-functional team to ensure the required sources of data can be accessed and accurate data gathered.
Analysis of data to ensure appropriate actions are taken, such as updating technical documentation or device improvements, is performed according to predefined criteria.
During this free 60 minute webinar hosted by Carolyn Guthrie, Director of QA/RA at Kapstone Medical, you will learn why it is important that PMS is not a one-size fits all approach, with considerations for risk of device, lifetime of device, time of the market, and more.
Specifically this webinar will cover:
Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our homepage to learn more.
Kapstone Medical, founded in 2007, is a single-source service provider to medical device companies lacking the appropriate human capital to commercialize new and safe products. We offer customized solutions that are flexible and cost effective in an ever changing regulatory environment. Our services span five main areas: product development, quality assurance, regulatory affairs, intellectual property strategy, and manufacturing solutions. Visit our homepage to learn more.