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Biocompatibility Regulations: Key Insights for Device Development

October 24, 2024 / October 7, 2024 by ebi_admin | Leave a Comment
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Endotoxin Testing in Biocompatibility: Key Insights

October 21, 2024 / October 7, 2024 by ebi_admin | Leave a Comment
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Top 5 Biocompatibility Tests for Medical Device Approval

October 14, 2024 / October 7, 2024 by ebi_admin | Leave a Comment
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Biocompatibility Testing: A Guide for Medical Device Manufacturers

October 7, 2024 / October 7, 2024 by ebi_admin | Leave a Comment
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Lab Expertise in FDA and EU MDR Regulations: Meeting the Needs of Medical Device QA Managers

September 30, 2024 / September 16, 2024 by ebi_admin | Leave a Comment
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Understanding the Role of Biological Evaluation Plans (BEP) in Medical Device Development

September 23, 2024 / September 16, 2024 by ebi_admin | Leave a Comment
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How Many Samples Are Needed for Biocompatibility Tests?

September 16, 2024 / September 16, 2024 by ebi_admin | Leave a Comment
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How to Create a Comprehensive Biological Evaluation Report (BER) for Regulatory Success

September 9, 2024 / September 9, 2024 by ebi_admin | Leave a Comment
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Exploring Key ISO Standards in Medical Device Biocompatibility Testing (Part 3)

September 2, 2024 / September 9, 2024 by ebi_admin | Leave a Comment
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Guide for QA Managers to Meet MDR Expectations for Biocompatibility Testing

August 26, 2024 / August 20, 2024 by ebi_admin | Leave a Comment
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How to Choose the Right Biocompatibility Tests for Your Medical Device

August 19, 2024 / August 20, 2024 by ebi_admin | Leave a Comment
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Navigating Biological Evaluation for Medical Devices: Key Insights from ISO 10993-1

August 15, 2024 / August 20, 2024 by ebi_admin | Leave a Comment
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ISO Standards Associated with Medical Device Biocompatibility Testing | Part 2

August 5, 2024 / August 9, 2024 by ebi_admin | Leave a Comment
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Understanding ISO 10993-1: A Comprehensive Guide for Medical Device Manufacturers

July 29, 2024 / July 17, 2024 by ebi_admin | Leave a Comment
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Common Fears of Quality Assurance Managers in Choosing Biocompatibility Laboratories

July 22, 2024 / July 17, 2024 by ebi_admin | Leave a Comment
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Understanding the Risks of Non-Trusted Laboratories in Product Testing

July 19, 2024 / July 17, 2024 by ebi_admin | Leave a Comment
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Complement Activation in Hemocompatibility Testing for Medical Devices

July 8, 2024 / July 9, 2024 by ebi_admin | Leave a Comment
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Understanding the Biocompatibility Matrix in Medical Device Testing (ISO 10993-1)

July 1, 2024 / June 28, 2024 by ebi_admin | Leave a Comment
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ISO Standards Associated with Medical Device Biocompatibility Testing | Part 1

June 24, 2024 / June 28, 2024 by ebi_admin | Leave a Comment
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Unveiling the Importance of Biocompatibility Testing for Bone Implants: Insights and Recommendations

June 10, 2024 / May 20, 2024 by ebi_admin | Leave a Comment
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Navigating Endotoxin Level Specifications for Medical Devices: A Comprehensive Guide

June 3, 2024 / May 20, 2024 by ebi_admin | Leave a Comment
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The Significance of Acute Systemic Toxicity Testing in Biocompatibility Assessment: Insights from Notified Bodies

May 27, 2024 / May 20, 2024 by ebi_admin | Leave a Comment
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FDA’s Rule on Laboratory Developed Tests (LDTs): Implications for Medical Device Manufacturers

May 20, 2024 / May 20, 2024 by ebi_admin | Leave a Comment
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An Overview of the Buehler Sensitization Test in Biocompatibility Assessment

May 15, 2024 / May 15, 2024 by ebi_admin | Leave a Comment
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      • Biological Evaluation Plan (BEP)
      • Chemical Characterization
      • Cytotoxicity
      • Sensitization
      • Irritation
      • Material mediated pyrogenicity
      • Toxicity
      • Implantation
      • Hemocompatibility
      • Genotoxicity
      • Biological Evaluation Report
    • Extractables & Leachables
      • Toxicological evaluation
      • Other
    • Biological reactivity USP
      • USP <87>
      • USP <88>
  • BLOG
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  • FAQ
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