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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...

How to Create a Comprehensive Biological Evaluation Report (BER) for Regulatory Success Introduction In the medical device industry, the Biological Evaluation Report (BER) is a pivotal document that summarizes the results of biological safety testing and provides an...

Exploring Key ISO Standards in Medical Device Biocompatibility Testing (Part 3) Continuing our journey through the realm of medical device biocompatibility testing, we delve into additional critical ISO standards that play pivotal roles in ensuring the safety and...

Guide for QA Managers to Meet MDR Expectations for Biocompatibility Testing The Medical Device Regulation (MDR), which governs the introduction of medical devices into the European market, sets rigorous standards for ensuring the safety and performance of medical...

How to Choose the Right Biocompatibility Tests for Your Medical Device Biocompatibility testing is a critical component in the development of medical devices, ensuring that they are safe for human use and do not cause adverse biological responses. Given the diversity...

Navigating Biological Evaluation for Medical Devices: Key Insights from ISO 10993-1 Introduction Biological evaluation is a critical aspect of medical device development, aimed at ensuring that devices are safe for human use. ISO 10993-1 offers comprehensive...

ISO Standards Associated with Medical Device Biocompatibility Testing | Part 2 In the dynamic landscape of medical device development, ensuring biocompatibility is paramount. Building upon our exploration from part 1, where we delved into standards such as ISO 10993-1...

Understanding ISO 10993-1: A Comprehensive Guide for Medical Device Manufacturers Introduction The development and commercialization of medical devices require adherence to stringent regulatory standards to ensure their safety and efficacy. One such critical standard...

Common Fears of Quality Assurance Managers in Choosing Biocompatibility Laboratories Quality assurance (QA) managers in the medical device industry face several significant fears when selecting biocompatibility laboratories to test their products. These include...

Understanding the Risks of Non-Trusted Laboratories in Product Testing In the realm of product testing, the integrity of laboratory data is paramount. Recent reminders from regulatory bodies, such as the FDA’s notice about fraudulent and unreliable laboratory...

Complement Activation in Hemocompatibility Testing for Medical Devices Introduction   The biocompatibility of medical devices, particularly those that come into contact with blood, is critical for ensuring patient safety and device efficacy. One essential aspect...

Understanding the Biocompatibility Matrix in Medical Device Testing (ISO 10993-1) Introduction   In the realm of medical device development, ensuring biocompatibility is a critical step in safeguarding patient safety and device efficacy. Biocompatibility refers...

ISO Standards Associated with Medical Device Biocompatibility Testing | Part 1 Introduction   In the realm of medical device development, ensuring biocompatibility is a critical step in safeguarding patient safety and device efficacy. Biocompatibility refers to...

Unveiling the Importance of Biocompatibility Testing for Bone Implants: Insights and Recommendations Biocompatibility testing stands as a critical aspect in ensuring the safety and efficacy of bone implants, paving the way for advancements in orthopedic treatments and...

Navigating Endotoxin Level Specifications for Medical Devices: A Comprehensive Guide Endotoxin levels are a critical consideration in the biocompatibility assessment of medical devices, ensuring patient safety and regulatory compliance. Understanding the...

The Significance of Acute Systemic Toxicity Testing in Biocompatibility Assessment: Insights from Notified Bodies Biocompatibility testing serves as a cornerstone in ensuring the safety and efficacy of medical devices. Among the array of tests employed, the Acute...

FDA’s Rule on Laboratory Developed Tests (LDTs): Implications for Medical Device Manufacturers The FDA’s recent announcement regarding Laboratory Developed Tests (LDTs) marks a significant milestone in the regulation of in vitro diagnostics medical devices...

An Overview of the Buehler Sensitization Test in Biocompatibility Assessment Introduction One crucial aspect of biocompatibility assessment is evaluating the potential for sensitization, where a material or component triggers an allergic reaction in patients. The...

Essentials for Crafting a Comprehensive Pre-clinical Study Report in Medical Device Biocompatibility Testing Introduction   In the realm of medical device development, pre-clinical studies play a crucial role in assessing the safety and efficacy of new products...

The “Big Three” in Biocompatibility Testing: Exploring the Vital Assessments Introduction   Biocompatibility testing is a crucial aspect of product development in the medical device industry. Ensuring that medical devices are safe and compatible with biological...

Cytotoxicity: MEM Elution Method in Biocompatibility Testing Introduction   Biocompatibility testing is a critical aspect of medical device development, ensuring that devices are safe and compatible with biological systems. Among the various tests conducted,...

Insights into Extractables & Leachables Testing: Ensuring Medical Device Safety In the realm of medical device testing, ensuring safety is paramount. Extractables & Leachables testing (ISO 10993-18) plays a pivotal role in this process, offering a...

Toxicological Evaluation: A Cornerstone of Ensuring the Safety and Efficacy of Medical Devices Toxicological evaluation (ISO 10993-17) is a cornerstone of ensuring the safety and efficacy of medical devices. At NABI, we specialize in providing comprehensive testing...

AMES Bacterial Reverse Mutation Test and its Role in Biocompatibility Evaluation   The AMES test, also known as the Bacterial Reverse Mutation Test, is a widely recognized assay used to evaluate the mutagenic potential of chemical substances and materials....

Testing Methods: A Comprehensive Look at In Vitro and In Vivo Approaches In the realm of medical device testing, ensuring biocompatibility is paramount to guaranteeing safety and efficacy. At NABI, we are dedicated to providing comprehensive solutions for...

The Significance of Biological Risk Assessment (BRA) in Biocompatibility Testing Introduction:   Biocompatibility testing stands as a cornerstone in ensuring the safety and efficacy of medical devices. Within this multifaceted testing landscape, the Biological...

Significance of the VOCs in Chemical Characterization for Biocompatibility Assessment in Medical Devices Introduction:   Biocompatibility is a critical aspect of medical device development, ensuring that devices interact safely and effectively with the human...

The Crucial Role of Biological Evaluation Plan (BEP) in Biocompatibility Testing Introduction:   Biocompatibility testing stands at the forefront of ensuring the safety and efficacy of medical devices intended for use within the human body. With the ever-evolving...

Understanding MTT in Cytotoxicity Testing for Biocompatibility Assessment of Medical Devices Introduction:   Biocompatibility testing plays a crucial role in ensuring the safety and efficacy of medical devices. Among the various tests employed, MTT...

The Role of Chemical Characterization in Ensuring Medical Device Safety Chemical characterization is a fundamental step in evaluating the safety and efficacy of medical devices. At the North American Biomedical Institute (NABI), we recognize the critical importance of...

Navigating the Regulatory Landscape: A Roadmap to Successful Medical Device Development The regulatory landscape in the biomedical industry is complex and ever-evolving. Navigating through the intricate web of regulations is crucial for the successful development of...

Navigating the Path to Success: Selecting the Right Medical Device Testing Laboratory In the intricate world of medical device development, ensuring the safety and efficacy of your product is of paramount importance. This is where medical device testing comes into...

Biocompatibility Testing Beyond Compliance: NABI’s Approach to Excellence Biocompatibility testing is a critical phase in medical device development, and at the North American Biomedical Institute (NABI), we approach this process with a commitment to excellence...

Demystifying Biocompatibility: A Comprehensive Guide to ISO 10993 Standards Biocompatibility serves as the cornerstone of ensuring the safety and efficacy of medical devices. At the North American Biomedical Institute (NABI), our commitment to this critical aspect of...

Ensuring Your Medical Device Meets the Highest Standards: Why and When to Test In the world of healthcare, ensuring the safety and efficacy of medical devices is paramount. This is where medical device testing comes into play. Why test your medical device? There are...

The Crucial Role of GLP Certification in Medical Device Testing In the ever-evolving landscape of medical device testing, the importance of adhering to rigorous standards cannot be overstated. Good Laboratory Practice (GLP) certification stands as a cornerstone,...

Biocompatibility and Chemistry: Cornerstones of Medical Device Safety In the world of healthcare, where innovation plays a pivotal role in improving patient outcomes, medical devices have emerged as indispensable tools. However, these devices, when interacting with...