End-to-End High-Quality
PMPF Surveys for EU MD Compliance
The Only MedTech Company

That offers ISO 14155 Compliant
PMPF Surveys

Understanding PMPF Surveys for IVDR

Post-Market Performance Follow-up (PMPF) surveys are essential for compliance with the In Vitro Diagnostic Regulation (IVDR). These surveys help manufacturers gather real-world data on the performance of their diagnostic devices after they have been placed on the market. PMPF surveys provide critical insights into the safety and efficacy of products, ensuring continuous monitoring and improvement. At Cetas Healthcare, we specialize in designing and conducting PMPF surveys that meet the stringent requirements of the IVDR, helping you maintain compliance and enhance product quality.

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Our Approach to IVDR Compliance

Cetas Healthcare takes a comprehensive approach to IVDR compliance. Our team of experts collaborates with you to develop a tailored PMPF survey strategy that aligns with your specific needs and regulatory requirements. We leverage our deep understanding of the IVDR framework to ensure that our surveys are thorough, accurate, and actionable. From initial planning to data collection and analysis, we handle every aspect of the PMPF process with precision and expertise, providing you with the insights needed to make informed decisions and maintain compliance.

By choosing Cetas Healthcare as your partner, you gain access to:

Proven Excellence

Benefit from our extensive experience in the medical device industry and our successful track record in conducting PMPF surveys.

Regulatory Compliance

Stay ahead of the game with our in-depth understanding of the IVDR framework, ensuring your products meet the necessary regulatory obligations.

Robust Data Analysis

Leverage our expertise in data collection, analysis, and interpretation to derive meaningful insights that inform product enhancements and patient safety improvements.

Global Perspective

Tap into our global network and understanding of regional requirements, enabling you to navigate the complexities of the international market.

Collaborative Partnership

Experience our commitment to building strong, long-lasting relationships with our clients, based on open communication, transparency, and trust.

The Only Partner You'll Need From Conception to Completion

Design PMPF/PMPF Survey Plan

Real World Evicence / Data Collection

Analysis of Survey Data

PMPF Evaluation Report

NB Liaison

See Our Clinical & Regulatory Services Portfolio Here

Get Started with Your PMPF Survey Today

Ensure your diagnostic devices remain compliant and perform optimally with Cetas Healthcare’s PMPF survey services. Our team is ready to assist you in navigating the complexities of IVDR compliance and providing the necessary support to achieve successful outcomes. Contact us today to learn more about how we can help you with your PMPF survey needs and take the first step towards enhanced regulatory compliance and product performance.

Blogs

Leveraging PMCF Surveys to Resolve Real-World Data Collection Issues for Legacy Medical Devices.

In the rapidly evolving landscape of medical devices, ensuring patient safety and product effectiveness is of paramount importance. Post-Market Clinical Follow-up (PMCF) surveys have emerged as a powerful tool for gathering real-world data and insights,

Can the Fusion of Market Research and Regulatory Considerations Drive Informed Decisions for Medical Device Manufacturers?

The fusion of market research and regulatory considerations can provide valuable insights and help medical device manufacturers make informed decisions when choosing a market for their product launch. Here’s how the combination of these two

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