Post-Market Surveillance is an area of emerging concern around the world. Not just a procedure for PMS, but an actual product-specific plan for gathering post-production data about your product or product family.
How do you make sure your device remains safe and effective once it’s on the market? It’s called medical post-market surveillance (PMS), a system that provides continuous feedback about a device on the market in order to maintain a high standard of product quality. PMS is a regulatory requirement in major markets like Europe, United States and also in Ukraine.
When done right, your PMS system can improve your device, provide better service to your users, and reduce the risk of adverse events before they happen. But with a myriad of regulatory obligations looming over you, implementing a PMS system can be overwhelming.
What is the difference between PMS and vigilance?
What are the key elements of a PMS system?
How should a PMS system function?
What is the role of risk management in PMS?
How do I implement data collection and review procedures?
How does a PMS system benefit my company?
We can answer all of these questions and many more. Please, contact to us.
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