Biocompatibility: Applying the New ISO 10993 Standards
A new updated ISO 10993-1 standard came out in Aug of 2018 that drastically changed how we access medical devices for biocomaptibility. We also are dealing with the impact of the Medical Device Regulations in Europe. The timing of these two documents has greatly disrupted the medical device industry. In this webinar we will discuss the changes and efficient approaches to navigate through the troubles.
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2-part Webinar: Navigating the ISO 10993-1:2025 & Challenges Encountered During ISO 10993-18 Testing
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Six steps to ISO 13485:2016 Certification and MDSAP Certification
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The FDA Drug Development Process: GLP, GMP and GCP Regulations
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Developing Biocompatibility for Medical Devices - Audrey Turley
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Understanding PDA/ANSI Standard 06-2025: A Roadmap for Culture Change
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Medical Devices - ISO 14971 : Risk Management
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ISO 10993 1 Key update on the new revision of this critical standard
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Design Controls - Requirements for Medical Device Developers
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Ethylene Oxide Sterilization Validation
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Behind the Scenes of Target’s Cyber Fusion Center
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Updates Coming to ISO 10993 1
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Recording of Usability Process Webinar
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Nitinol in Medical Devices: Shape Memory and Superelasticity (ft. Dr. Jerald Redmond) | Ep. 20
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Applying a Risk Based Approach to Biological Evaluation of Medical Devices Based on the ISO 10993:18
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How to Prepare a Medical Device 510k Submission for FDA | Rob Packard | Joe Hage
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ISO 14971:2019 & TR 24971 Explained - Medical Device Risk Management
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Supplier Evaluation & Assessment How to Meet FDA QSR & ISO 13485 Requirements
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How to Simplify Your Compliance with the New ISO 13485:2016
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The Complete ISO 42001 Certification Roadmap For 2026 (FREE AI Governance Course)
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