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Want to hear and learn about the latest trends in E&L analysis? Be sure to check out the below webcast!

Join NAMSA on August 2 at 10a Central Time for our webinar on "The Chemical Characterization Puzzle: Is There a Solution?" Our experts will address challenges faced by manufacturers and provide insights on how to effectively address them. We'll discuss the importance of designing studies that generate data suitable for global agencies and ensure regulatory compliance. We'll also explore best practices for obtaining accurate study results through collaboration between device manufacturers and laboratories. Learn about the significance of comprehensive analysis in ensuring the safety and efficacy of medical devices. Register now: The Chemical Characterization Puzzle: Is There a Solution? | NAMSA

Released: Application of Human Factors Engineering Principles for Combination Products: Questions and Answers Guidance for Industry and FDA Staff Sep,2023 This guidance focuses on considerations for the application of HFE principles to combination products comprised of a medical device combined with a drug or a biological product submitted for review in CBER, CDRH, or CDER.

At first glance, I don't see whether ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices, is still the main reference. Thanks.

🔬 Exciting Read! Explore the chemical characterization and toxicity evaluation of Ala®sil in our latest scientific article. 📑 We delve into the nuances and emphasize the importance of adhering to the Medical Device Regulation 2017/745. Stay informed, stay ahead! 💡👩🔬 #VisionRD #ScientificResearch #MedicalDeviceRegulation #ToxicityEvaluation #InnovationInHealthcare

Join NAMSA on August 2 at 10a Central Time for our webinar on "The Chemical Characterization Puzzle: Is There a Solution?" Our experts will address challenges faced by manufacturers and provide insights on how to effectively address them. We'll discuss the importance of designing studies that generate data suitable for global agencies and ensure regulatory compliance. We'll also explore best practices for obtaining accurate study results through collaboration between device manufacturers and laboratories. Learn about the significance of comprehensive analysis in ensuring the safety and efficacy of medical devices. Register now: The Chemical Characterization Puzzle: Is There a Solution? | NAMSA https://lnkd.in/ghVZR2vf

Is iTeraCare FDA approved? | Prife International iTeraCare devices and therapies are based on terahertz technology, which is safe, non-invasive and terahertz technology has been approved by the U.S. Food and Drug Administration (FDA). It is important to us to offer you the peace of mind that comes with the approval and endorsement of such a prestigious regulatory agency. Is TeraHertz radiation dangerous? Terahertz radiation is not harmful to humans at low powers. It is a type of non-ionizing radiation, i.e. it does not have enough energy to break chemical bonds. For this reason, it does not cause the same damage as ionizing radiation, such as X-rays […] https://lnkd.in/eb-awD4j

Join NAMSA on August 2 at 10a Central Time for our webinar on "The Chemical Characterization Puzzle: Is There a Solution?" Our experts will address challenges faced by manufacturers and provide insights on how to effectively address them. We'll discuss the importance of designing studies that generate data suitable for global agencies and ensure regulatory compliance. We'll also explore best practices for obtaining accurate study results through collaboration between device manufacturers and laboratories. Learn about the significance of comprehensive analysis in ensuring the safety and efficacy of medical devices. Register now: The Chemical Characterization Puzzle: Is There a Solution? | NAMSA

▶ Medical device chemical characterization, particularly in the context of Extractables and Leachables (E&L) assessment, is a crucial aspect of ensuring the safety and efficacy of medical devices. Over the past few years, there have been notable developments in regulatory expectations and changes in this field, reflecting a growing emphasis on comprehensive chemical testing to address potential risks . ⏸ Due to safety concerns Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Organization for Standardization (ISO) have issued guidelines and standards to guide manufacturers in conducting E&L assessments. Join here: https://bit.ly/3X8G7en #Extractables #leachables #medicaldevice #ExtractablesRegulations

Join NAMSA on August 2 at 10a Central Time for our webinar on "The Chemical Characterization Puzzle: Is There a Solution?" Our experts will address challenges faced by manufacturers and provide insights on how to effectively address them. We'll discuss the importance of designing studies that generate data suitable for global agencies and ensure regulatory compliance. We'll also explore best practices for obtaining accurate study results through collaboration between device manufacturers and laboratories. Learn about the significance of comprehensive analysis in ensuring the safety and efficacy of medical devices. Register now: The Chemical Characterization Puzzle: Is There a Solution? | NAMSA