Expertise.
Post Market Surveillance.
Ensure the quality and compliance of your products through effective post-market surveillance.
Compliant?
Do your Post Market Surveillance processes meet the latest regulatory requirements?
Proactive?
Do you recognize potential risks in good time and react quickly to security incidents?
Efficient?
Are you optimizing your monitoring processes to ensure sustainable product quality?
Secure your Post Market Surveillance.
Post Market Surveillance.
Our Post Market Surveillance (PMS) solutions help you to efficiently monitor your products after market launch and identify potential risks at an early stage.
As part of the MDR and other international regulations, life science companies must continuously monitor their products even after market launch. Our PMS services support you in setting up structured monitoring, creating reports and minimizing risks.
Our services include:
- Creation of PMS plans: Structured planning for continuous monitoring of your products.
- Compliant reporting: preparation of reports in accordance with MDR, IVDR and other international regulations
- Risk analysis and measures: Identification of potential security risks and implementation of preventive measures.
Post Market Surveillance Services at a glance.
Our Post Market Surveillance Services support you in all areas of monitoring and risk analysis.
Creation of PMS plans.
- Development of comprehensive monitoring plans for your products
- Ensuring compliance with regulatory requirements
- Ongoing review and adjustment of plans
Reporting in accordance with the rules.
- Preparation of PMS reports in accordance with MDR/IVDR
- Regularly review and update your reports
- Preparation for official audits and inspections
Risk analysis and measures.
- Identification of potential risks after market launch
- Development and implementation of risk management measures
- Tracking and monitoring of security incidents
Successful Post Market Surveillance projects in the life science industry.
Our Post Market Surveillance projects help companies to optimize their surveillance processes and meet regulatory requirements.
Implementation of a PMS system for a medical technology company
Optimization of reporting for a pharmaceutical company
Risk analysis and measures for a biotechnology company
Challenge.
A medical technology company needed a comprehensive post-market surveillance system to ensure MDR compliance.Measures.
- Development of a PMS plan in accordance with the MDR requirements
- Training the team to implement the monitoring processes
- Implementation of a system for tracking security incidents
Results.
- Full MDR compliance
- Improved traceability and risk management
- Efficient reporting and preparation for audits
Success.
The company was able to successfully implement its PMS system and fulfill all regulatory requirements.Optimize your Post Market Surveillance!
Our Post Market Surveillance Service Portfolio.
Our Post Market Surveillance portfolio supports you in meeting regulatory requirements and minimizing potential risks after market launch.
Our experts develop detailed post-market surveillance plans to ensure that your products are continuously monitored and that all regulatory requirements such as MDR and IVDR are met. We work closely with your team to tailor the surveillance plan to your products and markets. We ensure regular reviews and adjustments to the plans in order to take new regulatory requirements and market changes into account at an early stage.
The creation of PMS reports is a crucial step in ensuring the compliance of your products. Our team ensures that all reports meet current regulatory requirements, be it for MDR, IVDR or other international standards. We offer you continuous support in maintaining and updating your reports to keep them up to date. In addition, we prepare you comprehensively for regulatory audits and inspections to ensure that your documentation meets all requirements.
Effective risk analysis is crucial to identify potential safety incidents early after market launch. We help you implement a systematic risk monitoring system that quickly identifies problems and develops preventative and corrective actions. Our monitoring system ensures that all safety incidents are tracked promptly and appropriate risk mitigation measures are taken. This not only ensures the quality of your products, but also minimizes risks in the long term and ensures sustainable compliance.
Our PMS service includes both proactive and reactive monitoring strategies to ensure that potential security risks are identified at an early stage. We help you to implement proactive measures for continuous data collection to minimize risks before problems occur. At the same time, we support you with reactive measures to respond quickly after incidents such as complaints and to ensure safety.
For class IIb and III devices and implantable devices, we offer you a comprehensive service for creating and regularly updating PSUR reports. These reports ensure that the latest safety monitoring results are correctly recorded and analyzed. We ensure that all relevant data such as sales volumes, risk assessments and safety incidents are included in the reports.
Our PMS service is closely linked to risk management in accordance with ISO 14971. We support you in continuously updating your risk assessments based on the data collected in the PMS. Our experts work with you to track security incidents and adapt and improve your risk management based on real user experiences.
With our technology-based PMS solutions, we implement automated tools and digital platforms that enable efficient monitoring of your products. By collecting and analyzing data in real time, we ensure that potential problems are quickly identified and resolved. We also support you in creating and maintaining reports for authorities to ensure the long-term safety and performance of your products.
Ensure the compliance of your products with an efficient PMS system.
Related topics for post-market surveillance.
These complementary services help you to ensure the safety and compliance of your products after market launch:
