Latest From Cetas Healthcare

EU Medical Device Regulation (MDR), Therapeutic Goods Administration (TGA), Medical Devices Bureau (MDB), Pharmaceuticals and Medical Devices Agency (PMDA), Federal Office of Public Health (FOPH), International Medical Device Regulators Forum (IMDRF), Brazilian Health Regulatory Agency (ANVISA), National Medical Products Administration (NMPA) and Central Drugs Standard Control Organization (CDSCO)

How does an EU MDR certificate pave the way for accessing other markets?

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

Doctors wearing VR simulation with hologram medical technology, 5 Imperatives for MedTech Companies

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

PMPF Surveys for IVD Products, Ensuring Safety and Compliance

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, A Quick Guideline to Perform Conformity

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 ,Understanding PMPF Surveys for IVDR

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, PMPF Surveys for IVDR

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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