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Backfiltration as a result of transmembrane pressure conditions in the dialyser

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Backfiltration as a result of transmembrane pressure conditions in the dialyser

Editor’s note: This article is an English translation of the original German article, “Dialyse-Spezialwissen: Intradialytische Prozesse,” written by Gerd Breuch and originally published in the fnb eJournal, Issue 03/26. The original German version is available here. This English translation is...

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2026 MedTech Regulatory Outlook: EU MDR/IVDR, FDA QMSR, AI & Cybersecurity

In 2026, medical device and IVD manufacturers are navigating a moving-target regulatory landscape. In the EU, MDR/IVDR implementation continues while EUDAMED enters a mandatory-use phase. In the U.S., FDA’s Quality Management System Regulation (QMSR) is now in effect, aligning 21...

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Accelerating MDR Readiness for MedTech Start-ups – Engineering the Path to Compliance

Developing an innovative medical device is challenging — especially for start-ups navigating complex MDR and FDA requirements with limited resources and tight timelines. At D.med Technologies, we help MedTech start-ups build compliance from the design stage, turning regulatory complexity into...

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See you at COMPAMED 2025!

From 17 to 20 November 2025, D.med Technologies will be present at COMPAMED 2025 in Düsseldorf, Germany. As the world’s leading trade fair for suppliers and manufacturers in medical technology, COMPAMED brings together thousands of industry experts, innovators, and decision-makers...

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Design Controls for Medical Devices: FDA & ISO Guidance

Design controls form the backbone of both compliance and innovation in the medical device industry. They ensure that every product is developed in accordance with stringent safety, performance, and regulatory requirements. Under the U.S. FDA’s 21 CFR 820.30, manufacturers are...

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Another extension for the MDR transition period?

The Medical Device Regulation (MDR) has significantly reshaped the regulatory landscape in the European Union. With multiple deadlines, ongoing challenges, and growing concerns among industry experts, the transition remains a complex process for manufacturers. Here’s a comprehensive look at the...

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Guidelines to Adaptive Designs in Medical Device Clinical Studies

Introduction Adaptive designs have revolutionized clinical trials, especially in medical device development. These designs allow preplanned modifications based on interim data, maintaining the integrity and validity of the study while enhancing flexibility and efficiency. The U.S. Food and Drug Administration...

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How to approach FDA regulations for your medical device

Bringing a medical device to market in the United States requires navigating a complex regulatory landscape, primarily regulated by the Food and Drug Administration (FDA). Understanding the classification, regulatory pathways and compliance requirements is critical to success. At D.med Technologies,...

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Vital signs measurement: A thriving market driven by technological advances and evolving healthcare needs.

Introduction to Vital Signs measurement Vital signs are the essential indicators of the body’s basic functions, reflecting the state of an individual’s health. Monitoring these signs is crucial in medical settings to assess the immediate and long-term health status of...

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D.med Technologies Acquires GPE, Expanding Expertise in MedTech

Introduction D.med Technologies announced a significant milestone in our journey toward advancing healthcare innovation. D.med Technologies is proud to confirm the successful acquisition of GPE, a leading medical technology consulting firm based in Worms (Germany). GPE possesses unique expertise in...

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