Latest From Cetas Healthcare

PMPF Surveys for IVD Products

Ensuring Safety and Compliance: A Comprehensive Guide to Conducting PMPF Surveys for IVD Products

Introduction: As the regulatory environment progresses, ensuring the safety, performance, and compliance of In Vitro Diagnostic (IVD) products is of paramount importance. One key aspect of post-market surveillance is conducting Post-Market Performance Follow-up (PMPF) surveys.

Medical Devices in Europe under the EU MDR 2017/745

Introduction: The European Union Medical Device Regulation 2017/745 (EU MDR) has brought significant changes to the regulatory landscape for medical devices in Europe. Conformity assessment plays a crucial role in ensuring the safety and performance

Post-Market Clinical Follow-up (PMCF) - 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,

Market Research and Regulatory Considerations Drive Informed Decisions for Medical Device

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

Market Research, MedTech Product, Clinical and Regulatory Services

MedTech product managers often use Customer Insights or Voice-of-Customer analysis to gain market insights and make evidence-based decisions for their New Product Development (NPD) activities or new product launches. We regularly collaborate with numerous MedTech

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