Post market surveillance
Our experts provide PMS services to help you systematically gather, record and analyze relevant data on the quality, performance, and safety of your medical device throughout its entire lifetime.
Post market surveillance services
Post market surveillance is a crucial part of the medical device lifecycle and is emphasized in both EU MDR 2017/745 and EU IVDR 2017/746. The manufacturer’s Post Market Surveillance (PMS) system must proactively and systematically gather, record and analyze relevant data on the quality, performance, and safety of the medical device throughout its entire lifetime. As a manufacturer, you are obliged to collect and assess relevant information not only about your own device but also about related devices from competitors.
We can compile the PMS Plan, carry out the scheduled activities and produce the PMS Report or Periodic Safety Update Report (PSUR). We monitor subsequent updates to device technical documentation, risk management, and labeling.
Post Market Clinical Follow-up (PMCF) and Post Market Performance Follow-up (PMPF)
A key piece of the PMS is also the Post Market Clinical Follow-up (PMCF) for MDR and the Post Market Performance Follow-up (PMPF) for IVDR, where manufacturers must systematically record and evaluate clinical data regarding the safety and performance of their device.
We can compile the PMCF or PMPF plan, perform the activities as scheduled, analyze and report the findings, support you in implementing any preventive or corrective measures, and update the clinical evaluation plan/report. When required for your implantable or Class III medical device, we draw up and update the Summary of Safety and Clinical Performance (SSCP).
Our post market surveillance services include:
- PMS procedures
- PMCF/PMPF plans and reports
- Collecting data/Literature review
- Surveillance and assessment of upcoming changes in relevant standards and regulations
- Training (custom or open training)
- Complaint and Vigilance handling (including FSCA/FSN)
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Regulatory strategy
We help you develop an efficient regulatory strategy to meet applicable regulations, mitigate risks, and accelerate time-to-market for your medical device.
Market registrations
Let our team of experts support market registrations of your medical devices in the EU, US and other markets.
Digital health and cybersecurity
Dedicated regulatory and quality experts to help you streamline your medical software development and ensure that you adhere to local and global regulations.
Technical documentation
Expert support in planning, preparing and updating your technical documentation to help you ensure compliance with applicable regulations.
Clinical evaluation
Proven expertise in planning and conducting a thorough clinical evaluation that supports the regulatory approval of your medical device.
Performance evaluation
Dedicated experts in planning and conducting a thorough performance evaluation that supports the regulatory approval of your IVD medical device.
Biological evaluation
We support you in planning and conducting a thorough biological evaluation of your medical device that is compliant with ISO 10993-1.
Risk management
Medical device risk management services for setting up and maintaining your risk management process and helping you prepare your documentation.
Usability engineering
Support for your usability engineering activities, from creating a process to preparing a usability engineering file for your medical device.
Due diligence
Quality and regulatory experts ready to support your due diligence projects with comprehensive appraisals of medical device businesses.
Person Responsible for Regulatory Compliance (PRRC)
Our experts can support you in understanding the full range of PRRC responsibilities.
Quality management system services
QMS services for medical device manufacturers to help you design, implement and manage your QMS to support your organization's needs.
US FDA QMSR
Expert guidance on the US FDA's QMSR and other US regulatory requirements to help medical device manufacturers successfully enter the US market.
Auditing services
Improve your quality management system with our internal auditing services for medical device manufacturers.
Post market surveillance
Post market surveillance services to help you systematically gather and analyze data on the quality, performance, and safety of your medical device.
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We prioritize transparency, dependability, and delivering high-quality results.
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