Regulatory consulting firm Maetrics, is offering a free whitepaper aimed at outlines current regulatory requirements globally and explains how manufacturers worldwide can achieve post market surveillance compliance.
We’ve argued for a long time that medical device safety issues are most effectively picked up with effective post-market surveillance. Regulatory consulting firm Maetrics, reports that regulators are heightening post market surveillance(PMS), implementing stringent requirements for more PMS mechanisms, instead of relying on current reactive systems, such as complaints monitoring.
To rubberstamp its presence as one of the leaders in its field, Maetrics is offering a free whitepaper that is available to download here. The guide reviews the global climate that has led to increasing scrutiny on post market surveillance. It details:
· How manufacturers can successfully review post market surveillance systems, processes and procedures in time for the next Regulatory Body Audit or review
· The varying post market surveillance requirements in different geographies
· The expectations of different regulating bodies
· Challenges facing manufacturers
· Practical examples of dealing with challenges
· The role of personnel training in investigations and vigilance reporting
Report author Parminder Kalle, Senior Manager, Solutions Delivery at Maetrics comments: “post market surveillance of medical devices has not always been at the forefront of the minds of medical device manufacturers, but due to recent high profile scandals, regulatory bodies across the globe are starting to impose more prescriptive requirements for post market surveillance and manufacturers cannot afford to shirk on compliance. Ensuring the early detection of device issues via post market surveillance is a key activity as it is critical to protecting patient safety.”
“But manufacturers can also draw some immediate benefits from improving their post market surveillance as their devices enjoy improved reputation, there will be fewer complaints leading to lower handling and resolution costs and finally, having proactive post market surveillance investigation processes in place allows organizations to easily spot product, design and process improvements.”