News2024-06-26T08:50:33+00:00

News and Updates

Clinical Evaluation Report (CER) for MDR: Structure, Strategy, and Compliance

April 22, 2025|

Understanding the Clinical Evaluation Report (CER) When it comes to medical devices, proving clinical safety and performance is not just good practice, it’s a regulatory requirement. The Clinical Evaluation Report (CER) is the document that systematically collects and evaluates all [...]

CDSCO speeds up the process: automated certificates for medical devices

April 16, 2025|

India has introduced a new step toward regulatory efficiency in the MedTech sector. Yet something has shifted for medical device manufacturers in India: the Central Drugs Standard Control Organization (CDSCO) has launched an automated certification process. There was no official [...]

Post-Market Surveillance: A Swiss perspective on critical compliance gaps

April 2, 2025|

We’ve previously highlighted how important post-market surveillance (PMS) is, not just as a regulatory requirement, but as an essential tool for safeguarding patient safety and monitoring device performance throughout its entire lifecycle. Today, we’re revisiting the topic with a focus [...]

Hemodialysis bloodlines shortage: FDA alert and clinical implications

March 21, 2025|

The U.S. Food and Drug Administration (FDA) has recently issued a communication to healthcare providers regarding an ongoing shortage of hemodialysis bloodlines, a critical component in both acute and chronic dialysis treatments. These devices, responsible for connecting a patient’s blood [...]

Conditional CE certificates: A new pathway for faster market access?

March 17, 2025|

Over the past few years, the medical device industry has been navigating a complex regulatory landscape with the implementation of MDR 2017/745 and IVDR 2017/746. While these regulations have strengthened safety and performance standards, they have also created a bottleneck [...]

Data integrity in medical device testing – A critical FDA concern

March 14, 2025|

Why data integrity in medical device testing is more important than ever The FDA’s Center for Devices and Radiological Health (CDRH) has recently intensified its scrutiny of data integrity in medical device testing, and for good reason. The agency has [...]

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