Regulators in most medical device markets require registrants to meet post-market surveillance (PMS) obligations to maintain compliance. However, PMS rules can vary between different medical device markets, requiring manufacturers to develop tailored rather than one-size-fits-all approaches.
With deep expertise in post-market surveillance requirements, Emergo is equipped to act as your compliance partner long after your device goes on the market. We can help you design and implement a PMS system that meets requirements in multiple markets and navigate regulatory challenges throughout the device lifecycle.
Emergo represents more than 2,000 medical device and IVD companies as an official in-country representative, so we are constantly helping companies with vigilance reporting in markets worldwide, including:
We can help determine when incidents are reportable and ensure vigilance reports are completed on time and in compliance with local requirements.
Our experts have in-depth product knowledge covering a wide range of functional and technical disciplines that support medical device post-market risk management activities. From designing and executing a post-market clinical follow-up (PMCF) study to conducting a root cause analysis of your device in response to an adverse event, we collaborate with you to deliver a proprietary solution to your post-market needs.