Blogs. Social media. Online forums. Product reviews. While postmarket clinical follow-up (PMCF) studies, user surveys, clinical registry studies, electronic health records, and insurance claims data are all important sources of proactive data, most complaints will never cross your desk. Instead, users will often take to online forums and social media to voice their concerns. These potential sources of postmarket surveillance (PMS) data are probably not high on your priority list. After all, trying to extract relevant and actionable PMS data […]» Read more
How Much Postmarket Surveillance (PMS) Data Should We Have In Our Clinical Evaluation Reports (CERs)?
One of our customers recently asked this question, and it’s a good one. Much has been written about the need to maintain clinical evaluation reports (CER) throughout the entire life cycle of devices. There has been far more emphasis on postmarket surveillance (PMS) reporting in recent years, and the result is that clinical evaluation reports for established devices now often include a substantial amount of PMS data. Thus, when medical device regulatory professionals compile required postmarket reports, they rightfully wonder […]» Read more
The Unique Device Identification (UDI) system was conceived as a means of harmonizing identification of medical devices throughout the distribution chain and at the point of use. UDI is required on labeling for Class II and III devices sold in the US (Class I enforcement begins September 2022), and you are likely aware that it’s coming soon under the EU MDR. Less commonly known is the fact that other countries and regions around the globe are also beginning to require […]» Read more
How do I define a PMS objective? What postmarket data needs to be collected? How do I analyze it? What’s the connection to other QMS processes such as risk management? As many QA/RA practitioners know all too well, these questions are not well addressed in ISO 13485:2016 and ISO 14971:2019. The goal of this technical report (it’s not a full standard) is to share best practices on how to interpret the general postmarket requirements of the European Medical Device Regulation […]» Read more