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