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https://lnkd.in/enTiBC9U DLC test | Differential Leucocyte count test क्या होता है ? #DLCTEST #bloodtest #bloodtesting #differentialleucocyte Read Medical articles - https://lnkd.in/gijsxi3a

Adam’s Hand from BionIT Labs got PDAC approval for code L6880, making it accessibile through the Center for Medicare and Medicaid Services reimbursement!   The Adam’s Hand is currently the only multi-articulating hand on the US market covered by L6880 code which offers at the same time:   🚿 water- and dustproof IP67 rate ⚙️ field-serviceable components 🏋️♀️ highest carry load in the category   🎯 These features, together with its unparalleled durability and intuitive dexterity, makes it an excellent choice for users with upper limb differences! If you want to trial the Adam’s Hand free of charge, contact BionIT Labs at: https://lnkd.in/d49nG48j  #prosthetics #prosthetichand #AdamsHand #BionITLabs #bionichand #amputee #limbdifference #limbloss #manobionica #prosthesis #Device #CPOs #Medicare #Medicaid #US #user #reimbursement #PDAC

The SAFERTOS Design History File is designed to comply with 21 CFR 820 requirements, providing robust documentation and testing evidence for your Major Level Of Concern submissions. Adhering to the guidelines for premarket submissions for software in medical devices, this file ensures thorough and reliable compliance. Key features include: ✅ Detailed planning, design, and verification documents for your specific processor/compiler combination ✅ Supports critical functions in devices such as defibrillators and surgical robots Trust SAFERTOS to streamline your certification process and uphold the highest standards in safety-critical applications. https://lnkd.in/eiQ22nsU #DesignHistoryFile #21CFR820 #MedicalDevices #SoftwareCompliance #RTOS #SafetyCritical #MedicalSoftware #EmbeddedSystems

Want to know more about Simq VIT? 💡 Check out some of our FAQs for a quick dive into the details! 1. Is our patient data secure at all times? Yes, we have implemented many privacy and security features (only encrypted, pseudonymized geometry data is sent to the infrastructure). Furthermore, hosting our Azure infrastructure as a “Managed Application” is possible. This means that data sovereignty always remains with our customers. 2. Is it possible to include other anatomical regions? Yes, the software can be used for almost every human and animal body region. 3. Does Simq VIT have FDA/MDR approval? Simq VIT supports the design process of implants and is not a medical device. With our FDA-compliant report, which is always adapted to the latest changes, the technical documentation of our customers is always up to date. Anything else you would like to know? 👉 Visit us for more info: https://hubs.ly/Q02rPF300 #SimqVIT #ImplantDesign #Medical #PatientData #FAQs

Elegance via Simplicity. Full 360 in ~7 minutes: 1. Unboxing, 2. Placement, 3. Programming, 4. Removal Enjoy!  :-)

The Flip the Pharmacy team is hitting the road and so should you! Tiffany Capps, Chelsea Anderson, and Weston Humphreys will teach you how to optimize your med sync workflow and what a successful med sync program can bring to your pharmacy. Learn more about med sync and CPESN Networks at Catalyst Connect. Register today by clicking the flame icon in your PioneerRx software- and don't forget your boots! #CatalystConnect

It's a thumbs up for the IVDR deadlines! 👍 ⏰Class D (the high-risk ones) have until December 31, 2027. ⏰Class C? You’ve got until December 31, 2028. ⏰And if you’re dealing with Class B or Class A Sterile, mark your calendars for December 31, 2029. The move is meant to help the industry, especially with those trickier Class D devices, and it’s nudging manufacturers towards using Eudamed more. Are you surprised or not? 🤔 #IVDR

The NEW MDR PRO is here!

Starting a personal brand as a founder can be challenging, but with innate storytelling skills like Kent Yoshimura's, it happens naturally. If you have that "it" factor, don't hesitate—grab a camera, hit record, and watch your personal brand propel your business's growth. Shoutout to Jonathan Sopla Campuzano for pulling off this incredible edit and integrating new AI editing workflows into Magnify Media. #videoediting #AIediting #foundercontent

So this #MDCG 2023-7 guidance came out yesterday. It attempts to clarify #MDR articles 61.4-6, cases when #clinicalinvestigations are not required for #implants and class III #medicaldevices. Additional guidance is provided on “sufficient levels of access to the data” required for #equivalence claims in various scenarios. What stands out for me: 👉 This guidance once again clarifies that clauses 61.4, 5, and 6 exclusively apply to implants and class III devices. 👉 Some useful pointers for demonstrating sufficient levels of access to data of the equivalent device are provided in the table "Hierarchy of levels of access to device equivalence data" in Appendix II of this guidance. 👉 #PMCF is mentioned multiple times. As MEDDEV 2.12/2 indicated already more than a decade ago: when a manufacturer claims equivalence, there is an expectation that PMCF is performed to confirm the safety and performance of the device under evaluation. Happy holidays everyone 🎄 #regulatoryaffairs #regulatorycompliance #medicaldeviceregulation #clinicalresearch #postmarketsurveillance