Medical Device Management & Consulting consulting@regpromedical.com +1 (425) 241 - 3092
RegPro Medical
We know WHAT to do. We do it RIGHT. The FIRST Time.
Post-Market Surveillance Plan
Post-Market Surveillance is a continuous process throughout the lifecycle of every medical device. Valuable information is compiled from manufacturing, sales, complaints, servicing, customer feedback, and ongoing clinical and scientific developments in the relevant medical specialty. This information is analyzed and interpreted to inform safety and risk management decisions and can help drive innovation and improvement. Effective Post-Market Surveillance starts with a detailed and well-organized Post-Market Surveillance Plan. The European Union in particular requires specific elements in a Post-Market Surveillance Plan and Post-Market Clinical Follow-up Plan.
What will RegPro Medical Do?
RegPro Medical will partner with you to generate a Post-Market Surveillance Plan that is effective and meaningful and meets the regulatory requirements as well as your own goals and objectives. We will help you develop an effective plan to keep your fingers on the pulse of the customer’s requirements and the overall market, to identify potential problems before they become bigger, inspire new product features and innovations, and maintain your state-of-the-art status in the market.
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Create or update Post-Market Surveillance Plan
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Create or update Post-Market Clinical Follow-up Plan
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Help define Post-Market Surveillance metrics and objectives
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Help develop effective Post-Market Feedback program