PMS/PMCF
YOUR TASK
From market entry, you have to regularly analyse and evaluate the safety and performance data for your medical device to ensure that no new hazards or higher risks arise (benefit-risk assessment). As part of the PMS activities, you ensure the continuous, proactive collection of relevant clinical data on your product with PMCF activities.
YOUR NEEDS
We focus on your demands.
Is your Notified Body criticising your PMS system and requesting additional PMCF activities?
Would you like to identify and analyse new risks on the basis of empirical evidence?
Do you want to identify previously unknown side effects and monitor known side effects and contraindications?
Do you need to ensure the ongoing justifiability of your benefit-risk analysis and the adjustment of your Risk Management?
Would you like support in identifying applications outside the intended purpose (“misuse”) of your device?
Are you looking for external know-how and independent expertise?
OUR SERVICE
As part of a gap analysis, we thoroughly examine your PMS system. We help you close the identified gaps in your Quality Management System and define suitable processes with correct interfaces between responsible teams.
PMS / PMCF AT A GLANCE
We support you in the development of customized solutions for your PMS / PMCF system.
1
Projekt Kick-off
Together, we determine the scope and strategic approach of your PMS project. We establish a timeline that takes your goals, outcomes, and deadlines into account. Additionally, we discuss the exchange of all necessary documents.
2
Gap-Analysis
During the gap analysis, we examine whether your PMS system complies with the MDR (Regulation (EU) 2017/745) and if the product-specific PMS/PMCF documentation is complete. The results are discussed and documented in a report. Based on the results, the PMS/PMCF system can be adjusted, appropriate data sources and methods can be selected, and the documentation for your product can be updated.
3
PMS-Plan / PMCF- Plan
We describe the data sources and methods you have established for the necessary activities. Attention is paid to the existing interfaces within the Quality Management System to ensure that the measures can be carried out efficiently. All steps up to the creation of the reports are planned.
4
Execution of agreed activities
- Research in scientific databases and data analysis for updating the State of the Art
- Monitoring of the benefit/risk assessment along with the update of the Clinical Evaluation
- Evaluation of complaints and identification of PMS-relevant events (clinical and non-clinical; serious and non-serious; expected side effects)
- Analysis and determination of actions (such as CAPA, FSCA, and recalls) and trends, including statistical methods
- Preparation of vigilance reports
- Supervision of PMCF studies and other PMCF activities
5
PMS-Report or PSUR
Depending on the classification of your medical device, we create initial reports and regularly update them for you.
6
Initiation of measures
Should the analyzed data show that corrective or preventive measures are necessary, or even measures in the field, we will work with you to implement these within the framework of the legal requirements. This includes compliance with any reporting deadlines.
Contact our experts!
Do you have any further requests?
Regular PMSR/PSUR updates
We support you in the regular data collection, analysis and preparation of PSURs or PMS reports for your medical devices.
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GAP Analysis
We thoroughly review your PMS documentation. Depending on your individual needs, we either work with your templates or use our tried and trusted ones.
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