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 Report
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 to keep your marketing edge. The European Union in particular requires specific activities and detailed documentation for Post-Market Surveillance and Post-Market Clinical Follow-up (PMCF). The Post-Market Surveillance Report or Periodic Safety Update Report (PSUR) require ongoing updates on a defined schedule. Compiling, analyzing, and documenting the Post-Market Surveillance information on a recurring schedule for all of your products can be a resource challenge.
What will RegPro Medical Do?
RegPro Medical will work with you to execute your Post-Market Surveillance Plan and generate the Post-Market Surveillance Report or PSUR on schedule and efficiently. We will gather, organize, and document the information relevant for your medical device as designated in the Post-Market Surveillance Plan, and work with your team to analyze and interpret the data to finalize a Post-Market Surveillance Report or PSUR that meets the regulations and provides valuable insights into the customer satisfaction, commercial success, and the safety and risk profile of your medical device.
-
Create or update Post-Market Surveillance Report or PSUR
-
Help evaluate and interpret Post-Market Surveillance data
-
Facilitate Regulatory and Notified Body Post-Market review and response