Amarastesia and CerA&Mvix, a game changer in atraumatic cervical canal instrumentation and Safe Pass-through for instruments have reached incredible Milestones: 1. Functional prototype 2. FDA presubmission meeting 3. Strong partnerships with International Academic Centers. Many thanks to Dr. Kurian Thott for his leadership, support and excellence in R&D.
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Looking for a new opportunity where science, analytical chemistry, expertise, coaching of people and operational skills could be of added value
interesting topic and great presenter, highly knowledgeable in this domain
📢 Heading to MEDevice Silicon Valley? Don’t miss this must-see presentation by Thor Rollins, VP Global Segment Leader, Medical Device at Nelson Labs. ⤵️ Presentation: ISO 10993-1: Key Meeting Updates and Future Directions – Navigating the Latest Changes and Next Steps in Biological Evaluation of Medical Devices. Gain exclusive insights into the latest updates from the October ISO meetings, including a stronger risk-based approach, enhanced chemical characterization, and key shifts in genotoxicity and end-of-life evaluations. Learn how these updates impact your biocompatibility strategies and regulatory pathways. Don’t miss this opportunity to stay ahead in medical device safety and compliance! Learn more and stop by our booth #1402 to speak with us: https://lnkd.in/gXGqtEVS #ISO10993 #Biocompatibility #MedicalDevices #MEDeviceSiliconValley
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Helping Industrial, Medical and Transportation OEMs scale by outsourcing their design and manufacturing.
An #FDA surveillance inspection puts every corner of a #medtech manufacturing facility under the microscope. 🔬 Their goal? To confirm that every step is documented, traceable, and fully compliant. 📋 When ESCATEC recently prepared for an #FDAinspection, it was more than just paperwork - we wanted to be sure that our systems and processes were ready and fully transparent for the team to interrogate. 🔍 If you're curious about the ins and outs of FDA inspections, including why they matter for choosing a reliable medtech manufacturing partner, check out our latest blog post. ⤵️ https://hubs.ly/Q02YG-7-0
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🔬 Explore the gold standard in biocompatibility testing with us at Biocompatibility Testing! Our comprehensive evaluations ensure the safety and compatibility of medical devices and materials. From cytotoxicity to sensitization testing, trust our expertise for regulatory compliance and product safety. Visit biocomptesting.com to learn more! #BiocompatibilityTesting #MedicalDevices #SafetyTesting 🔍💉
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Our E&L expert, Dujuan Lu, will be part of a Roundtable Discussion on Trends, Best Practices, and Analytical Challenges in Chemical Characterization of Medical Devices. This webcast is sponsored by Agilent and presented by LCGC International. It is on Thursday June 27 at 8:00 AM PDT / 11:00 AM EDT / 4.00 PM BST and 5:00 PM CEST. Don't miss out, sign up here 👉https://lnkd.in/eU6hpkEc More information below 👇 #drugdevelopment
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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!
Our E&L expert, Dujuan Lu, will be part of a Roundtable Discussion on Trends, Best Practices, and Analytical Challenges in Chemical Characterization of Medical Devices. This webcast is sponsored by Agilent and presented by LCGC International. It is on Thursday June 27 at 8:00 AM PDT / 11:00 AM EDT / 4.00 PM BST and 5:00 PM CEST. Don't miss out, sign up here 👉https://lnkd.in/eU6hpkEc More information below 👇 #drugdevelopment
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In this weeks blog we discuss the importance of Cytotoxicity testing in Medical Device Biological Evaluation. Cytotoxicity is a biological endpoint for all medical device types that have contact with patients/users. Testing is carried out inline with the requirements of ISO 10993-5. To find out more about cytotoxicity testing please read our blog. https://lnkd.in/e8mDUH3j #cytotoxicity #iso10993 #medicaldevice #biologicalevaluation #patientguard
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Executive Director Business Development | Preclinical Medical Device Testing Services | Labcorp
Cytotoxicity testing is a critical step in medical device evaluation, but it comes with many challenges. Factors like device composition, sample preparation and contamination can impact results. With so much riding on safety data, it's essential to understand these challenges. Learn more about the key considerations for successful cytotoxicity assessments: #Biocompatibility #MedicalDevice
Why is cytotoxicity testing critical in medical device development?
learn-more.com
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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
Is iTeraCare FDA approved? | Prife International
https://iteracare.life/en/
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Cytotoxicity testing is a critical step in medical device evaluation, but it comes with many challenges. Factors like device composition, sample preparation and contamination can impact results. With so much riding on safety data, it's essential to understand these challenges. Learn more about the key considerations for successful cytotoxicity assessments: #Biocompatibility #MedicalDevice
Why is cytotoxicity testing critical in medical device development?
learn-more.com
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Cytotoxicity testing is a critical step in medical device evaluation, but it comes with many challenges. Factors like device composition, sample preparation and contamination can impact results. With so much riding on safety data, it's essential to understand these challenges. Learn more about the key considerations for successful cytotoxicity assessments: #Biocompatibility #MedicalDevice
Why is cytotoxicity testing critical in medical device development?
learn-more.com
