Newsletter | June 20, 2024

06.20.24 -- Clinical Investigation Plans: The Role Of MDCG 2024-3 In The Context Of EU MDR Annex XV, ISO 14155

FEATURED EDITORIAL

Clinical Investigation Plans: The Role Of MDCG 2024-3 In The Context Of EU MDR Annex XV, ISO 14155

The Medical Device Coordination Group (MDCG) published the new 2024-3 guidance document relating to clinical investigations of medical devices. How does it complement existing guidance and regulation?

The Global Cardiac Surgery Devices Market: Minimally Invasive Takes The Stage

New market research reveals a shift away from invasive open-heart surgery toward minimally invasive surgery, driven by transcatheter aortic valve replacements.

INDUSTRY INSIGHTS

Micro Molding And The Future Of Biomedical Applications

Micro molding innovations are revolutionizing biomedical device manufacturing with precision and scalability. Learn how this technology is shaping the future of patient care and medical advancements.

Best Practices When Connecting A Variable Volume Pump With A Fluidic System

Discover optimal fluid connection and mounting strategies for variable volume pumps, ensuring precise fluid control and system performance in your design process.

What Is A Robust Quality Management System And Why Does It Matter?

When we talk about partnering with OEMs, we often reference the fact we have a very robust quality management system (QMS). It sounds great, but what does it mean for you and what does it mean for us on a day-to-day basis? Why is it imperative that both organizations have an understanding of each other’s QMS?

Ready-To-Use Containers: A Smart Approach To Fill & Finish Operations

RTU containers are in demand, as they are supplied pre-washed and pre-sterilized and can be integrated directly into aseptic Fill & Finish lines. Find out about the latest RTU containment solutions.

ARTICLES YOU MAY HAVE MISSED

AI-Enabled Medical Devices In India: Opportunities And Challenges

A Critical Analysis Of FDA Human Factors IFU Guidance For Drug Delivery Devices

4 Critical Focus Areas For Medtech Compliance Leaders

China In The Global Medtech Industry: Equal Parts Promising And Uncertain

Sleep Apnea Market Sees Global Shift From CPAP To APAP Devices

RESOURCES

CarboSil Thermoplastic Silicone Polycarbonate Polyurethane (TSPCU)

Medical Grade Capacitors: MD Series

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