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The top documents of namsa
New FDA Refuse to Accept Policy for 510(k)s and Acceptance Review Process for PMAs
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Use of Chemical Characterization to Assess the Equivalency of Medical Devices and Materials
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Things to Consider When Validating Environmental Systems
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ISO 10993 Series Part 1: Evaluation and Testing In The Risk Management Process
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ISO 10993-6: Biological Evaluation of Medical Devices - Tests for local effects after implantation
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ISO 10993-5 Biological Evaluation of Medical Devices - Tests for In Vitro Cytotoxicity
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Common Mistakes in the Medical Device Development Continuum
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ISO 10993-3: Biological Evaluation of Medical Devices - Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
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ISO 10993-7 Biological Evaluation of Medical Devices - Ethylene Oxide Sterilization Residuals
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Introduction to NAMSA's Certification Program
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