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Understanding ASTM Tests in Medical Device Biocompatibility: Scope, Application, and Limitations In the world of medical device development, ensuring the biocompatibility and safety of materials is crucial. ASTM (American Society for Testing and Materials) standards...

Comprehensive Sum-Up: Recent Updates to the ISO 10993 Series Shaping the Future of Biocompatibility The landscape of medical device biocompatibility testing is undergoing significant transformations with recent updates to the ISO 10993 series. These revisions aim to...

How to Prepare for a Medical Device Product Audit: Key Steps, Requirements, and Insights for Success The Medical Device Regulation (MDR) classifies medical devices into four distinct categories based on the level of risk they pose to patients and users. Each category...

How to Define a Family of Medical Devices to Streamline and Reduce Biocompatibility Testing Requirements Medical device audits are a critical part of maintaining compliance and ensuring patient safety. For companies developing medical devices, preparing for these...

MDR Device Categories: How Medical Devices Are Classified in the EU The Medical Device Regulation (MDR) classifies medical devices into four distinct categories based on the level of risk they pose to patients and users. Each category determines the regulatory...

Can FDA-Approved Devices Be Sold in Europe Without MDR Compliance? For U.S. medical device manufacturers, gaining FDA approval is a major milestone, signaling that a product meets the rigorous standards for safety and efficacy required by the U.S. market. However, if...

What is the Difference Between MDD and MDR (in the EU)? For over two decades, the Medical Devices Directive (MDD) regulated the approval and sale of medical devices within the European Union. However, the introduction of the Medical Device Regulation (MDR) in 2017...

Understanding MDR: A Guide to Medical Device Regulations in the EU The Medical Device Regulation (MDR), officially known as Regulation (EU) 2017/745, is a critical piece of legislation that governs the approval and regulation of medical devices in the European Union...

Biocompatibility Regulations: Key Insights for Device Development Introduction Navigating the complex world of biocompatibility regulations can be a daunting task for medical device manufacturers. Understanding the regulatory landscape is crucial for ensuring...

Endotoxin Testing in Biocompatibility: Key Insights Introduction Endotoxin testing is a critical aspect of biocompatibility assessment for medical devices, particularly those that come into contact with the bloodstream or internal tissues. This article delves into the...