Post-Market Surveillance

Complying with PMS Requirements and Change Processing:

Post-Market Surveillance (PMS) is an essential requirement for ensuring the ongoing safety and efficacy of your in-vitro diagnostic (IVD) or medical device once it reaches the market.

We can assist you in understanding and managing the complex landscape of PMS, including Post Market Performance Follow-up (PMPF) and Post Market Clinical Follow-up (PMCF).

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.

PMS - Regulatory Affairs - QbD Group (2)

Vigilance reporting and training

Effective vigilance is a cornerstone of post-market safety. We support manufacturers with:

Serious incident reporting and follow-up corrective actions.
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.

Learn more about our vigilance support services.

Impact assessments

Assess the impact of changes to your regulatory submissions

Process development

Developing processes to meet the stringent requirements of the IVDR.

Post Market Follow-up

Conducting studies, literature reviews, and more as part of PMCF/PMPF.

Why partner with QbD Group?

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.

Get in touch to learn more about our Post-Market Surveillance services.