Post Market Surveillance Guidance

Celegence Provides Post Market Surveillance Guidance for Your Medical Device From a Global Perspective.

With the coming EU MDR, all manufacturers will require advanced PMS systems, processes, and personnel to manage these requirements. A medical device Post-Market Surveillance system should provide consistent information for devices already on the market. It is the key function to maintain your product is functioning correctly and at the highest possible safety level for users. With our help, adverse events become more preventable, and your PMS reports become far more manageable for your team.

Celegence can provide PMS guidance for your product from a global perspective. We specialize in major markets like the EU and the United States but have worldwide partners with expertise relevant to your needs. Our customizable solutions allow you to utilize our templates that are in accordance with regulation as well as your Notified Body requirements.

How Celegence Can Help:

  • Design your PMS plan

  • Research – including:

      • Indications for use
      • Regulation history, and device background
  • Build and develop schedules for follow-up assessment procedures
  • Data collection and statistical analysis
  • Guidance on Notified Body Interactions
  • Make sure your organizations meet interim and final data analysis requirements
  • Writing services related to Post Market Clinical Follow-up, Periodic Safety Update Report, Summary of Safety and Clinical Performance, Risk Management Plan and Report, Post Market Surveillance Plan and Report

Requisite MDR PMS Revisions:

  • Updating the benefit-risk determination
  • Updating the design and manufacturing information, the instructions for use, labeling etc.
  • Post Market Clinical Follow-up Plan and Report
  • Identify needs for preventive, corrective or Field Safety Corrective Action for the device
  • Contribute to the PMS of other devices (when relevant)
  • Detect and report trends as specified by article 88

Additional Information

Download the latest brochure of our capabilities and services.

DOWNLOAD MEDICAL DEVICE BROCHURE
In Vitro MDR Regulation Compliance - Celegence

Contact Us

If your organization requires assistance in any of the above EU MDR or FDA requirements, as well as other markets, our team is here to help.

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