Post-Market Surveillance – Continuous Assurance of Safety and Quality

 

The market launch of a medical device is only the beginning. With an effective Post-Market Surveillance (PMS) strategy, you can monitor the performance and safety of your products in real-world clinical use. Our experts develop customised PMS strategies that integrate seamlessly into your risk management system while ensuring full compliance with current regulatory requirements.

Our PMS services include:

  • Data analysis and evaluation: Collection and assessment of user feedback, clinical data, and safety reports
  • Risk management: Early detection of potential risks and proactive measures for product optimisation
  • Regulatory reporting: Preparation of PMS reports in accordance with MDR and other international standards
  • Continuous improvement: Adaptation of products and processes based on real-world performance data

Rely on our expertise in Post-Market Surveillance to ensure the sustained safety, quality, and performance of your medical devices—even after they have entered the market.

 

Post-Market Surveillance – Continuous Assurance of Safety and Quality

 

The market launch of a medical device is only the beginning. With an effective Post-Market Surveillance (PMS) strategy, you can monitor the performance and safety of your products in real-world clinical use. Our experts develop customised PMS strategies that integrate seamlessly into your risk management system while ensuring full compliance with current regulatory requirements.

Our PMS services include:

  • Data analysis and evaluation: Collection and assessment of user feedback, clinical data, and safety reports
  • Risk management: Early detection of potential risks and proactive measures for product optimisation
  • Regulatory reporting: Preparation of PMS reports in accordance with MDR and other international standards
  • Continuous improvement: Adaptation of products and processes based on real-world performance data

Rely on our expertise in Post-Market Surveillance to ensure the sustained safety, quality, and performance of your medical devices—even after they have entered the market.

 

Welcome to our Department of Clinical Research.

Willkommen in unserem Fachbereich für Klinische Forschung.