Understanding the IVDR classification system is crucial for compliance and market access in the EU. This blog breaks down the key aspects of IVDR classification, helping you navigate the complexities and ensure your in vitro medical devices meet regulatory requirements. Learn about the different risk classes, essential requirements, and steps for successful classification and CE marking. Get the insights you need to stay compliant 🔗: https://lnkd.in/eCQWyQ4n #IVDR #MedicalDevices #RegulatoryCompliance #InVitroDiagnostics #HealthcareInnovation
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https://lnkd.in/gRwVHJiz “Conway police stated in a Facebook post that medical examiners cited ‘complications from Sickle Cell Trait’ as the cause of Williams' death.” The medical examiners did not get this right. Blame Sherlock-style backward reasoning. The public notice offers the order of events that allows us to reason forward: 1. “Upon reaching the scene, a Conway Police Department officer engaged Deitric Williams, Jr., the suspected offender.” 2. “Following a brief conversation, Mr. Williams fled the scene, prompting a foot chase.” 3. “Subsequently, another officer responding to the situation discovered Mr. Williams behind a duplex and initiated an attempt to detain him.” 4. “Mr. Williams resisted…” 5. “…additional officers intervened…” 6. “…and eventually, he was placed in custody.” 7. “Mr. Williams indicated that he was in distress, prompting officers to call for medical assistance.” 8. “Mr. Williams was transported to the hospital. He later died while receiving medical treatment.” People who resist restraint become fatally exhausted, later to die in transport or in the hospital from complications. A focus on what happened allows us to see this. Medical examiners who examine a body focus on what they find in the body, then they reason backward to something they imagine rather than witnessed events. They see sickled red cells under the microscope, so they blame the decedent’s sickle cell trait for the complications. Sickle cell trait in other cases may be sufficient to cause death, but in this case, the struggle against police restraint was both sufficient and necessary for the death. Prior to his struggle, he was in apparent health in spite of his sickle cell trait and methamphetamine use. The moral of this story is two-fold: 1. Don’t resist the police. Let them arrest you without a struggle. “Lawyer up” when you get to the station. 2. Don’t pay attention to doctors who reason backward like Sherlock Holmes. #InferentialTest #SherlockEffect
Medical examiner rules Conway police in-custody death an accident | KATV
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Can lifestyle medicine provide better solutions than polypharmacy? We believe so...
How do you quantify drug induced MCI? How do you discern "naturally occurring" cognitive decline from polypharmacy? Get a clear picture, accurate diagnosis, and blueprint for intervention with Korebalance and Cognivue screening and treatment. Contact us info@medicalfitsolutions.com https://lnkd.in/ghDTJ6S #aging #dementias #parkinsons #MCI #healthcare #pharma #balance #cognition #evaluaton
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Early to bed and early to rise makes a man healthy, wealthy and wise. #quote #quotesoftheday #quotes #docmotez #doctorsapp #doctorappointment #doctorsmanagement #doctors #doctorlife #patientmanagement #physicians #patients #pharmacy
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How do you quantify drug induced MCI? How do you discern "naturally occurring" cognitive decline from polypharmacy? Get a clear picture, accurate diagnosis, and blueprint for intervention with Korebalance and Cognivue screening and treatment. Contact us info@medicalfitsolutions.com https://lnkd.in/ghDTJ6S #aging #dementias #parkinsons #MCI #healthcare #pharma #balance #cognition #evaluaton
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The FDA recently finalized a rule marking a significant shift in the regulation of laboratory-developed tests (LDTs). Here’s what you need to know: - New Classification: LDTs are now considered medical devices. - Enhanced Oversight: The new rule aims to ensure the safety and accuracy of LDTs. - 4-year phase-out period: Time is being given to allow labs and developers to adapt. - Selective Enforcement: The FDA will continue its existing enforcement policy, focusing on LDTs that do not address an unmet clinical need or predate the final rule. - Possible Challenges: The rule faces potential legal challenges hinging on broader legislative actions These shifts raise new concerns about LDT cost increases, potential treatment delays, and barriers to innovation. DKP understands that keeping up with these never-ending changes can be daunting. Our experts are masterful at helping organizations adapt to new regulations efficiently and effectively. We simplify complex regulatory landscapes so you can focus on what you do best—innovating and improving patient care. #oncology #alzheimers #pathology #patientcare #marketaccess #fda #ldts #ldt #laboratorydevelopedtest #laboratorydevelopedtests #precisionmedicine #medicaldevices
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Carbapenems, including meropenem, may cause CNS toxicity. Meropenem is associated with a lower seizure risk than imipenem/cilastatin and therefore may be preferred for certain indications. Other noteworthy CNS effects caused by meropenem include delirium, continuous epileptiform discharges, and myoclonic jerking. The risk factors for CNS toxicity are elevated in patients with preexisting neurologic conditions (eg, seizures, stroke, brain injury) or due to drug accumulation in patients with kidney impairment. If CNS toxicity occurs, discontinue the causative drug and replace it with another alternative. P.S. For more Health Tips, please follow me on #monyhealthniche #pharmacist #medicine #medical #fda #health #medicalwriter #medicalwriting #contentwriter #team #education #monyhealthniche #medicaleducation #medicalcare #medicalcommunications #drugsafety #nursing #medicalcourses #medicalcontent #medicalcommunity #writing #growth #career #experience #contentwriting #research #emergency #critical #MedComms #medcommsjobs #share #Marketing #socialmedia #InfectiousDisease
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Authentic -Change Agent- Lifelong Learner - Passionate PT clinician, leader and educator ....loving girlfriend, daughter, granddaughter, sister, Auntie and friend to my peeps
Happy to share my recent publication on a topic that has been near and dear to me for over two decades. Towards a Prescription for Change: Interprofessional Management of Polypharmacy and Deprescribing - #nonpharmacologicaltherapy #deprescribing #polypharmacy Perron, A.E. Towards a Prescription for Change: Interprofessional Management of Polypharmacy and Deprescribing. Curr Geri Rep (2024). https://lnkd.in/e7HVW_MD
Towards a Prescription for Change: Interprofessional Management of Polypharmacy and Deprescribing - Current Geriatrics Reports
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ACP| FCP| DFSEM | Multi professional educator | Guest lecturer| FCP Supervisor | Injection therapist | NASS Primary care Champion Independent prescriberI Physiozen owner/Founder| Exec comm member PCRMM
If you are #fcp and aspiring to become #nonmedicalprescriber or #independentprescriber SE2 Watch to learn more about #evidence and #opioid and #deprescribing #fcp #firstcontactphysio #physiostudent #physiotherapy_world #opioidepidemic #opioidawareness
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📢 Sepsis is the leading cause of death in U.S. Hospitals. 📢 Sepsis affects an estimated 49 million people worldwide each year. 📢 People develop sepsis more in the community than in the hospital 📢 87% of cases start from contracting infection at work, school, or home. Imagine what you can do with a head start to fight infection in-patient and remotely. www.temptraq.com #clinicaltrials #clinicalresearch #sepsis #sepsisawareness #earlydetection #corebodytemperature #continuousmonitoring #vaccines #feverdetection #remotepatientmonitoring #oncology #hematology #infectionprevention #infectiousdisease #cartcelltherapy #cytokinereleasesyndrome #fever #digitalhealth #fdacleared #pediatric #allages
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SVP/GM | Global Commercialization and Operations Leadership | Board Advisor | Digital Health | Diagnostic Imaging | AI | Medical Devices | MBA
Owlet Baby Care is dedicated to providing an infant monitoring solution for every caregiver and baby. We have ensured equity-based requirements in every stage, including design and analysis for Owlet's recent FDA submissions. The Owlet BabySat and Dream Sock have undergone clinical evaluation for SpO2 accuracy in skin tone ranges from Type 1-VI on the Fitzpatrick scale. Our pulse oximetry devices' accuracy has been demonstrated on patients of all skin colors, and there is no clinically significant difference in accuracy or bias between darker skin and white skin tone infants. Owlet's commitment to data-driven decision-making aligns with our mission and the FDA's pursuit of accuracy and fairness in healthcare technology. https://lnkd.in/e_N6PwrB #OnlyOwlet #HealthcareInnovation #FDA #HealthTech #DataDrivenHealthcare #digitalhealth
FDA renews debate over biased pulse oximeters
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