Latest From Cetas Healthcare

Explore Clinical & Regulatory Services Introduction: The convergence of proactive and reactive methodologies within a post-marketing surveillance (PMS) system can significantly enhance the effectiveness and robustness of medical device monitoring. By harmonizing these approaches, manufacturers

Introduction: ‘Sufficient clinical data’ is a critical term used in the context of medical device regulations to describe the level of evidence required to demonstrate the safety and performance of a medical device. It refers

Introduction: The EU Medical Device Regulation (MDR) is a set of regulations that govern the safety and performance of medical devices in the European Union. The MDR is one of the strictest medical device regulations

Medtech companies are expected to play a key role in the digital transformation of healthcare. Many are already prioritizing building digital capabilities in-house via investing in R&D, business models, and acquiring assets to expand their

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.

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

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,

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

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