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New FDA Refuse to Accept Policy for 510(k)s and Acceptance Review Process for PMAs
New FDA Refuse to Accept Policy for 510(k)s and Acceptance Review Process for PMAs
122 views
Use of Chemical Characterization to Assess the Equivalency of Medical Devices and Materials
Use of Chemical Characterization to Assess the Equivalency of Medical Devices and Materials
246 views
Practical Biostatistics for Clinical Trials: How to Find and Use Your Biostatistician
Practical Biostatistics for Clinical Trials: How to Find and Use Your Biostatistician
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ISO 10993-12 Sample Preparation and Reference Materials
ISO 10993-12 Sample Preparation and Reference Materials
143 views
ISO 10993 Biological Evaluation of Medical Devices Update
ISO 10993 Biological Evaluation of Medical Devices Update
722 views
Interim Analysis of Clinical Trial Data: Implementation and Practical Advice
Interim Analysis of Clinical Trial Data: Implementation and Practical Advice
168 views
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medical Device Market Entry
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medical Device Market Entry
519 views
Components of a Successful Packaging Shelf-Life Study
Components of a Successful Packaging Shelf-Life Study
149 views
Color Additives: Current Thoughts on Biological Safety
Color Additives: Current Thoughts on Biological Safety
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Meta Analysis of Medical Device Data Applications for Designing Studies and Reinforcing Clinical Evidence
Meta Analysis of Medical Device Data Applications for Designing Studies and Reinforcing Clinical Evidence
152 views
Current Regulatory Thinking In Reprocessing
Current Regulatory Thinking In Reprocessing
187 views
Aligning Global Regulatory Strategy to Decrease Approval Time in Emerging Markets
Aligning Global Regulatory Strategy to Decrease Approval Time in Emerging Markets
139 views
Introduction to NAMSA's Certification Program
Introduction to NAMSA's Certification Program
157 views
Things to Consider When Validating Environmental Systems
Things to Consider When Validating Environmental Systems
150 views
ISO 10993 Series Part 1: Evaluation and Testing In The Risk Management Process
ISO 10993 Series Part 1: Evaluation and Testing In The Risk Management Process
405 views
ISO 10993-4 Biological Evaluation of Medical Devices - Tests for Interactions with Blood
ISO 10993-4 Biological Evaluation of Medical Devices - Tests for Interactions with Blood
391 views
ISO 10993-6: Biological Evaluation of Medical Devices - Tests for local effects after implantation
ISO 10993-6: Biological Evaluation of Medical Devices - Tests for local effects after implantation
155 views
ISO 10993-3: Biological Evaluation of Medical Devices - Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
ISO 10993-3: Biological Evaluation of Medical Devices - Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
373 views
ISO 10993-7 Biological Evaluation of Medical Devices - Ethylene Oxide Sterilization Residuals
ISO 10993-7 Biological Evaluation of Medical Devices - Ethylene Oxide Sterilization Residuals
448 views
ISO 10993-5 Biological Evaluation of Medical Devices - Tests for In Vitro Cytotoxicity
ISO 10993-5 Biological Evaluation of Medical Devices - Tests for In Vitro Cytotoxicity
275 views