Post-Market Compliance

“Quality and Compliance is never an accident. It is always the result of intelligent effort.”
– John Ruskin

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 geographies, requiring manufacturers to develop tailored approach. With Our expertise in post-market surveillance, we are equipped to act as your compliance partner. We design and implement a PMS system that covers all requirements in multiple markets and navigate regulatory challenges throughout the device lifecycle.

Having in-depth knowledge covering a wide range of functional and technical disciplines, we support in designing and executing a post-market clinical follow-up (PMCF) study to conduct 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

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