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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...

Top 5 Biocompatibility Tests for Medical Device Approval Introduction For medical device manufacturers, understanding the essential biocompatibility tests is critical for meeting regulatory approval and ensuring patient safety. As regulatory scrutiny increases,...

Biocompatibility Testing: A Guide for Medical Device Manufacturers Introduction Biocompatibility testing is a crucial step in the development of medical devices, ensuring that products are safe for patient use. As regulatory requirements continue to evolve,...

Lab Expertise in FDA and EU MDR Regulations: Meeting the Needs of Medical Device QA Managers In the complex world of medical device development, ensuring compliance with regulatory standards is paramount. For Quality Assurance (QA) managers, this task often involves...

Understanding the Role of Biological Evaluation Plans (BEP) in Medical Device Development Introduction In the realm of medical device development, ensuring the safety and efficacy of devices is paramount. One crucial aspect of this process is the Biological Evaluation...

How Many Samples Are Needed for Biocompatibility Tests? Biocompatibility testing is a crucial step in the development and regulatory approval of medical devices. Ensuring that the device does not cause adverse biological responses when it comes into contact with the...