Breaking Down the "New" Biocompatibility Guidance on ISO 10993

While it's true that not much has changed, what HAS changed is significant - to your testing plan, to your timeline, and most importantly, to your budget.
Keywords: Medical devices, regulatory affairs, regulatory compliance, medical device risk management, quality management, quality management system, risk management, biocompatibility, biocompatibility testing, biocompatibility testing medical devices, ISO 10993, medical device regulatory affairs, medical device regulation, design control medical devices