Post-Market Surveillance
Ensuring ongoing safety and compliance
Post-Market Surveillance is an essential requirement for ensuring the ongoing safety and efficacy of your IVD or medical device once it reaches the market.
Comprehensive solutions for MD and IVD manufacturers
Our team of experts will work with you to develop a robust, EU-compliant PMS strategy tailored to your product's unique needs. This includes proactive monitoring of your device's performance and addressing regulatory requirements with confidence.
We also offer guidance on the change control process, ensuring any modifications to your product or documentation are handled efficiently and in full compliance with applicable standards.
How we can support your PMS needs
Our services are designed to simplify compliance and strengthen product performance.
Impact assessments
Assess the impact of changes to your regulatory submissions and determine the required follow-up actions.
Process development
Developing processes to meet the stringent requirements of the IVDR and MDR for post-market activities.
Post Market Follow-up
Conducting studies, literature reviews, and more as part of PMCF (Medical Devices) and PMPF (IVD) requirements.
Vigilance reporting and training
• Establishing a vigilance process, customized to align with your quality assurance (QA) system
• Assessing potential vigilance cases for reportability
• Comprehensive vigilance training for your team, empowering them to handle safety-related tasks with precision
Why QbD Group
Your trusted partner
With a deep understanding of regulatory frameworks and industry best practices, we offer expert guidance to ensure your PMS activities are compliant, effective, and seamlessly integrated into your operations. Let us help you enhance patient safety, ensure regulatory compliance, and maintain your competitive edge.
Deep expertise in MDR and IVDR post-market requirements.
Comprehensive PMS and vigilance system implementation.
Proactive approach to compliance and risk management.
Training and support for your internal PMS team.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.