Ensure continuous safety and performance for your IVD product

Proper risk management is the basis for an effective post-market surveillance. We support you in implementing the requirements of ISO 14971:2019 in an individual and practical risk management process. We also help you in applying usability engineering (IEC 62366:2016) and electrical safety (IEC 61010:2010) to reduce risk with safe design and protective measures.

As part of your product registration, the IVDR requires you to establish a post-market strategy to monitor the performance and safety of your product. We help you implement effective PMS to ensure clinical performance data is proactively collected, revised and updated. We can also help you execute CAPAs/FSCAs and communicate field safety notices in case of complaints.

Need suppport in risk management and post-market surveillance

Take advantage of our services:

  • Implementation of the IVDR and ISO 14971:2019 requirements into your risk management system
  • Implementation of usability engineering (IEC 62366:2016) and electrical safety (IEC 61010:2010) for IVD devices
  • Creation and review of plans for PMS and PMPF
  • Support with execution and completion of PMS and PMPF activities (e.g. surveys, clinical performance studies, continuous review of scientific literature or authority databases)
  • Development of PMPF study designs
  • Statistical data evaluation
  • Creation of PMS report, periodic safety update report and PMPF evaluation report
  • Trainings and workshops on
    • FMEA/FMECA in accordance with IEC 60812:2018
    • Risk assessment and control in accordance with EN ISO 14971:2019
    • Post-market surveillance

Please contact us if you want more Information or a non-binding offer on our Services for Risk Management and Post-Market Surveillance