For medical devices, sterility isn’t optional — it’s essential. Choosing the right Sterility Assurance Level (SAL) ensures regulatory compliance, patient safety, and product functionality. Key Factors for #SAL Selection: 1. Device classification and use 2. Risk assessment 3. Material compatibility 4. Regulatory and market requirements Read more about SAL 🚑 https://buff.ly/3VR5akT #SterilityAssuranceLevel #MedTech #EBeam #Sterilization
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Boost Your Medical Equipment Testing with Rigel Medical Guides: Biomedical engineers, check out Rigel Medical’s free guides to master best practices in medical equipment testing. The Infusion Pump Testing Guide covers: History of Infusion Types of Infusion Infusion Characteristics These resources are invaluable for ensuring accurate and safe testing. Highly recommended for refining your protocols and staying on top of industry standards! #BiomedicalEngineering #MedicalEquipment #RigelMedical #InfusionPumpTesting
Rigel Medical has created a number of free guides to help you understand best practices when testing your medical equipment; topics covered in the Infusion Pump Testing guide include: • The history of infusion • Types of infusion • Infusion characteristics • Testing infusion devices 👉Download Guide: https://ow.ly/wu7y50T7il5 #InfusionPumps #InfusionDevices #Biomed #IAmHTM #Bmet #ClinicalEngineering #FreeGuide #EducationalTools
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At RSSL, we pride ourselves in being experts in ensuring product quality. With the rise in anaphylaxis incidences, the demand for reliable auto-injectors to deliver life-saving medication has surged. When a medical device manufacturer approached us with a faulty auto-injector, we quickly leveraged our extensive analytical expertise to diagnose the problem and develop a precise method to measure the device's actuation force. Read our recent case study to see how our state-of-the-art facilities and expert technical knowledge helped get our client’s product back on track, ensuring quality and reliability when it matters most. https://lnkd.in/eFEfRmUp #MedicalDevice #AutoInjectors #ProductQuality #QualityAssurance
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𝗨𝗻𝗹𝗼𝗰𝗸𝗶𝗻𝗴 𝗦𝗮𝗳𝗲𝘁𝘆: 𝗔 𝗚𝘂𝗶𝗱𝗲 𝘁𝗼 𝗕𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗧𝗲𝘀𝘁𝗶𝗻𝗴 𝗜𝗦𝗢 𝟭𝟬𝟵𝟵𝟯 Explore the world of 𝗕𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗧𝗲𝘀𝘁𝗶𝗻𝗴 𝗜𝗦𝗢 𝟭𝟬𝟵𝟵𝟯 to ensure the safety and reliability of medical devices. Our guide covers essential insights and compliance strategies for industry professionals. Contact us now! Visit : https://lnkd.in/d_UPnaQq #biocompatibility #Biocompatibilitytesting #biocompatibilitytest
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🔍 Inherent Defects in Medical Devices: A Case Study 🔍 Recent legal actions against the Maxoniq OMX TMJ prosthesis highlight significant concerns about patient safety. One patient, Celina, claims that the device caused severe complications, including increased pain and nerve damage, and is suing for damages. This case underscores the importance of robust quality assurance in the medical device industry. At Sereni Health, we specialize in helping companies navigate regulatory challenges and enhance product safety. If you're looking to strengthen your compliance strategies or improve your quality management systems, let’s connect! #MedicalDevices #QualityAssurance #RegulatoryCompliance #SereniHealth https://lnkd.in/exKaVmCH
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🦴PainTEQ secures new patent for LinQ SI joint stabilisation system The patent expands PainTEQ’s single-use instrumentation portfolio and protects design features that improve procedural precision, efficiency, and patient safety. It introduces two key advancements in instrument alignment. Claims 1-6 focus on using a joint locator with a keying protrusion for alignment with the cannula via a guidance slot. Claims 7-12 expand the design by reversing the roles, positioning the protrusion on the cannula and the joint locator with a channel to receive it. The joint treatments developer said that these mechanisms offer a unique and effective approach to improve procedural accuracy and enhance patient outcomes. Read more online: https://lnkd.in/e6NK39Gi 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing
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Agree with you G. Wayne Moore that the definitions are invaluable, but the one challenge that still exists is, medical device manufacturers are the only people reading FDA guidance documents, the service organizations that might actually be stepping in the the remanufacturing arena aren't likely to look at the document so, now we have to continue to educate the product owners (e.g.; hospitals, clinics) so that they include reference to this guidance in their servincing contracts. #FDA #remanufacturing #service #safety
The FDA’s new guidance on remanufacturing marks a significant step forward in patient safety. By clearly defining remanufacturing versus servicing activities, the FDA ensures all medical devices adhere to the highest standards of safety and performance. Acertara is proud to support these advancements, providing top-quality ultrasound probe repair and testing services that fully align with the new Guidance document. #PatientSafety #FDA #MedTech Celebrate this milestone with us. Visit https://bit.ly/3RfNOtp for industry-leading ultrasound repair and testing services.
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Report code 98977 for the cost of employing a medical device, as defined by the FDA, to transmit data for monitoring the musculoskeletal system. Only report this code if data collection occurs for at least 16 days within a 30-day timeframe. Document the name and description of the device utilized for monitoring the musculoskeletal system. Learn more about reimbursement at SomaticHealth.com! #RemoteTherapeuticMonitoring #RTM #CPTCodes #MSK
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Report code 98977 for the cost of employing a medical device, as defined by the FDA, to transmit data for monitoring the musculoskeletal system. Only report this code if data collection occurs for at least 16 days within a 30-day timeframe. Document the name and description of the device utilized for monitoring the musculoskeletal system. Learn more about reimbursement at SomaticHealth.com! #RemoteTherapeuticMonitoring #RTM #CPTCodes #MSK
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The FDA has granted breakthrough technology status to single-use duodenoscopes, leading to CMS providing a pass-through payment. This additional reimbursement has made single-use devices the most economical option for Medicare outpatients in some institutions, leading to faster adoption. Dr. Raman Muthusamy believes that single-use devices will play a major role in the future, with the potential for rapid iteration and improvement. But what do you think? Obviously single-use devices can't be the solution for everything? How do you approach this balance in your role as an IP? You can hear our interview with him on this topic here: https://lnkd.in/gJsKmvt2 #TransmissionControl #Endoscopes #InfectionPrevention
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Lower your medical equipment costs, enhance transparency, and streamline #AssetManagement — all while ensuring continuity of care. Discover how #RaaSbyMEDILOGIX makes it possible! www.MEDILOGIXLLC.com/RaaS #DME #MEDILOGIX
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