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MedTech product development strategies to drive clinical studies.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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Impacting People's Lives
"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.
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Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.
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Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.
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Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. It's what we call Healthcare-grade AI.
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Your new expert analyst is here. Be at the forefront of data-driven decision-making with a new generative AI tool that enables you to interact with our products and solutions like never before. Get results you can trust, faster.
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The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.
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IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are. Our hybrid and fully virtual solutions have been used more than any others.
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VIEW ROLESInsight Brief
Biocompatibility: Trends & Best Practices for ISO 10993-1 Compliance
Mar 24, 2025
Discover the latest trends and best practices in biocompatibility for medical devices with our comprehensive Insight Brief, "Biocompatibility: Trends and Best Practices for ISO 10993-1 Compliance." Authored by Robert A. Allen, Ph.D., Director of Regulatory Affairs – Biocompatibility at MCRA, this brief is an essential resource for medical device manufacturers, regulatory professionals, and anyone involved in the development and compliance of medical devices. Dive into the critical aspects of biocompatibility testing for devices that come into contact with the human body and learn how evolving standards and regulatory guidance will shape the future of biocompatibility testing. Read how we've helped manufacturers implement innovative testing approaches, resolve FDA deficiencies, and meet Notified Body expectations.
Equip yourself with the knowledge and tools to navigate the complex landscape of biocompatibility for medical devices. Download the Insight Brief today to keep your devices aligned with the highest standards of safety and compliance. This brief also offers a forward-looking perspective on upcoming trends and regulatory changes.
Key Highlights:
- Learn about the cornerstone standard, ISO 10993-1:2018, and its importance in ensuring patient safety by preventing adverse effects from device materials.
- Explore how different regulatory bodies, including the FDA and the EU's Medical Device Regulation (MDR), interpret and enforce biocompatibility standards.
- Gain insights into adapting compliance strategies to meet regional regulatory expectations and streamline the approval process.
Understand the steps involved in material and chemical characterization as outlined in ISO 10993-18. - Discover the importance of identifying materials, evaluating biological risks, and assessing the impact of manufacturing processes on biocompatibility.
- Learn how to align biological evaluations with comprehensive risk assessments as per ISO 14971:2019.
- Find out how developing a Biological Evaluation Plan (BEP) can minimize regulatory deficiencies and unnecessary testing.
- Master the complexities of interpreting and reporting biocompatibility data in a Biological Evaluation Report (BER).
- Avoid common pitfalls in documentation and justifications to prevent delays or rejections during regulatory reviews.
- Stay ahead of the curve with insights into emerging trends, such as alternatives to ethylene oxide (EtO) sterilization and the impact of regulatory concerns over per- and polyfluoroalkyl substances (PFAS).