How to Use Biocompatibility to Evaluate Changes in a Medical Device
Medical devices often go through many changes throughout their normal product lifecycles. Whenever a device goes through one of these changes, it should also undergo a review to determine the impact the change had on the biological safety of the device. While many changes have little impact and can be justified based on the minimal risk, other changes (or a compilation of changes) could pose a serious biological safety impact and require a revalidation. This presentation will cover the questions manufacturers need to ask to determine what impact changes may bring to their devices and the testing that should be performed to measure the impact of these changes.
Bullet Points:
• How to use chemical characterization to evaluate a change
• Questions to ask to determine the biological impact of a change
• What if I am changing or adding a colorant?
• What testing do I need to repeat to demonstrate a change is safe?
• Determining the possible impact of changing to 3D printing
Видео How to Use Biocompatibility to Evaluate Changes in a Medical Device канала Nelson Labs
Bullet Points:
• How to use chemical characterization to evaluate a change
• Questions to ask to determine the biological impact of a change
• What if I am changing or adding a colorant?
• What testing do I need to repeat to demonstrate a change is safe?
• Determining the possible impact of changing to 3D printing
Видео How to Use Biocompatibility to Evaluate Changes in a Medical Device канала Nelson Labs
Показать
Комментарии отсутствуют
Информация о видео
Другие видео канала
Biocompatibility Explained: A Simple Understanding to a Complex Topic-ToxikonHow to Categorize a Medical Device per ISO 10993-1The Current State of Biocompatibility: How FDA & CE Are Looking at BiocompatibilityAssessing the Safety of Extractables and Leachables for Drug Products: When and How?Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical DeviceSciVid 2019 A Finalist: What are Biocompatible MaterialsThe Big Three: Cytotoxicity, Sensitization & Irritation TestingChemical Characterization & Toxicological Risk Assessment for Medical Device BiocompatibilityUpcoming Changes to Cleaning Validations for Reusable Medical DevicesHow To Perform The PYROGENT™ Gel Clot LAL AssayChemical Characterization: How to Initiate the Biological Evaluation of Medical DevicesFilter Sterilization ValidationsThermal Fogger Unboxing | How To Use Thermal Fogger Machine | Call Now - 7829055044Regulatory requirements of biocompatibility of medical devices and ISO 10993Develop a Risk Based Biological Safety Evaluation Per New US FDA Guidance: Understand Test OptionsCurrent regulatory trends around extractable & leachable testing, what we are hearing from the FDADrug device combination products Lise VanderkelenRealistic Job Preview: Environmental Monitoring TechnicianTesting of the packaging: Extractable study design and challengesNelson Lab Wiesbaden