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White papers, articles
and presentations
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FDA Guidance: Coronary, Peripheral, and Neurovascular GuidewiresButton Text
The Ten steps of Biological Evaluation within a Risk Management Process
In-Vivo Thrombogenicity
FDA Recognized Consensus Standards Update
ISO 18562-1 (2017) Biocompatibility Evaluation of Breathing Gas Pathways
3D printed Medical devices
Biocompatibility Deficiency Letters: Part 2
Mitigating Risk in Biocompatibility
The Failed Cytotoxicity Test
How to Pick a Biocompatibility Lab
USP <88> vs. ISO 10993 Class Tests
BIOCOMPATIBILITY DEFICIENCY LETTERS
Biocompatibility Gap Analysis
THE FIRST STEPS IN BIOCOMPATIBILTY
Post Approval Biocompatibility
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  • Home
  • Suppliers
    • Contract Laboratories >
      • Toxikon
      • Nelson Labs
      • Eurofins
    • Material Suppliers
    • Contract Manufacturers
    • Consultants >
      • Intrinsic Medical Group
  • Library
    • Which Endpoints Should I Consider?
    • Test Method Summaries
    • White Papers, Articles and Presentations >
      • FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires
      • FDA Recognized Consensus Standards Update
      • The Ten Steps of a Biological Evaluation whtin a Risk Management Process
      • Post-Approval Biocompatibility
      • The Failed Cytotoxicity Test
      • Biocompatibility Deficiency Letters Part 2
      • ISO 18562-1 (2017) Biocompatibility Evaluation of Breathing Gas Pathways
      • In-Vivo Thrombogenicity 101
      • Technical Considerations for Additive Manufactured (3D Printed) Devices
      • How to Pick a Biocompatibility CRO
      • Mitigating Risk in Biocompatibility
      • Biocompatibility Deficiency Letters
      • The First Steps in Biocompatibility
  • Contact
    • About
  • Search