MCRA is pleased to announce the addition of anesthesia and critical care as a new therapy specialization, led by former FDA Assistant Director Todd Courtney. With the growth in the number of medical devices for anesthesia and critical care, MCRA has hired Mr. Courtney as the Vice President of Anesthesia Regulatory Affairs. Read the full press release on our website now. #mcra #anesthesia #criticalcare #regulatoryaffairs #anesthesiaregulatory #fda #medicaldevice #medicaldevicecro #clinicalresearchorganization #medicaldevices
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Miss our webinar on the new FDA regulations for LDTs yesterday? You can watch the full webinar now and learn how MCRA's IVD experts can set you up for success on our website! Tune in now: https://lnkd.in/eW5JETyU #IVD #LDT #LDTs #LDTguidance #FDAguidance #FDAsubmission #QMS #qualitysystems #webinar #MCRA #regulatory #FDAregulatory #clinicalvalidity #clinicalstudy #clinicalresearch #CRO #medtech #biotech
LDT vs IVD: Adapting to the New FDA Regulations - MCRA Webinar
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Corporate compliance is essential to developing a successful MedTech organization. A good compliance program helps ensure companywide protocols that lead to patient safety, as well as market approval. By foregoing these services, your organization could end up in a costly and difficult position. Learn more about The Consequences of Non-Compliance, and reach out to MCRA's compliance team now: https://lnkd.in/eKFYhjTD #compliance #MCRA #complianceexperts #corporatecompliance #healthcarecompliance #medtech #medicaldevices #medicaldevice #biotech
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Deadline for submissions to OrthoPitch at AAOS 2025 Annual Meeting in San Diego is about one week away! Give your early and mid-stage company with novel, innovative and potentially disruptive orthopedic products the chance to shine, connect with top seed and early-stage investors, physicians, strategists and other industry members, along with other amazing opportunities and prizes for winners. Submissions close August 3rd, register here: https://lnkd.in/e8FrKDds American Academy of Orthopaedic Surgeons (AAOS) #AAOS2025 #AAOS #OrthoPitch #Orthopaedics #Orthopedics #MCRA #orthopedicimplants #orthopedicdevice #orthodevice #orthoexperts #orthopedicexperts
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MCRA's Kara Budor recently wrote on disagreements in device classification during MDR CE marking applications. Learn the best practices on how to move ahead when this issue arises. Read the latest on our website now! https://lnkd.in/ePAa3P2z #MDR #CEMark #EUMDR #europe #CEmarking #medtech #medicaldevices #regulatory #regulatoryaffairs #EUregulatory #NotifiedBody #medtechindustry #medtechinnovation #regulatoryconsultant #EUregulatory #devicemisclassification #deviceclassification
Oops! A Quick Quip on Device (Mis-)classification
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MCRA’s Spine team is the leader in assisting Spinal device companies navigate through the often complicated medical technology lifecycle. From research and development, through commercialization, MCRA’s experts partner with our clients every step of the way to maximize the success of their product launch. Partnering with over 500 spine companies, MCRA can help your company develop regulatory strategies for the FDA and Notified Bodies, including 510(k)s, CE Marks, De Novos, and PMAs. Find out more about our Spinal Services: https://lnkd.in/eCNZ2UiQ #MCRA #spine #spinedevice #spineimplant #MedTech
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The span and complexity of clinical studies demand a committed partnership with relationship continuity. CRO stability can seriously impact the quality of execution, ability to meet timelines, the amount of time and energy you will need to put into oversight, and site relationships. While no CRO can guarantee zero turnover on your team, the more stable the organization, the more likely it is that your trial will run smoothly and efficiently. In an industry known for a high rate of employee turnover, MCRA is proud of our lasting relationships and 90% employee retention rate. #MCRA #CRO #ClinicalResearch #MedicalTechnology #MedicalDevice #ClinicalResearch #Regulatory #Reimbursement #compliance #SpecializedTherapyExpertise Learn how to optimize your trials with advice from global clinical research experts. Contact us https://lnkd.in/ehwSCmAm
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Last chance to register! Join us tomorrow at 10 am EST for LDT vs. IVD: Adapting to the New FDA Regulations. MCRA’s Expert IVD Team James Mullally, Dan Goldstein, and Julie Martel, PhD will discuss the FDA’s final rule on the regulation of Laboratory Developed Tests (LDTs), the timeline for enforcement, key aspects of the rule, and how your organization can align with the new FDA requirements and more. Don’t miss out! Register here: https://lnkd.in/e8vFVenq #IVD #LDT #FDA #FDAregulation #FDAregulatory #FDAcompliance #qualityassurance #LDTvsIVD #webinar #laboratorydevelopedtests #FDArule #IVDregulation #MCRA
Register now for the LDT vs. IVD: Adapting to the New FDA Regulations Webinar! Join MCRA experts James Mullally, Julie Martel, PhD and Dan Goldstein on Tuesday, July 16th at 10am EST. With the recent FDA release of the final rule for Laboratory Developed Tests (LDTs), MCRA’s IVD and Quality Assurance team will walk you through FDA’s timeline for enforcement of LDTs, the key aspects of the ruling, and how your organization can align with this new FDA requirement. #IVD #LDT #LDTruling #FDA #FDAregulation #FDAregulatory #FDAcompliance #qualityassurance #LDTvsIVD #webinar #laboratorydevelopedtests #FDArule #IVDregulation
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Less than one month left to apply to OrthoPitch at AAOS 2025, deadline for submission is August 3rd! Early and mid-stage companies with novel, innovative and potentially disruptive orthopedic products are encouraged to apply. Get a chance to present to top seed and early-stage investors, physicians, strategists and other industry members, along with other amazing opportunities and prizes. https://lnkd.in/etHaMqGy American Academy of Orthopaedic Surgeons (AAOS) #AAOS2025 #AAOS #OrthoPitch #Orthopaedics #Orthopedics #MCRA #orthopedicimplants #orthopedicdevice #orthodevice #orthoexperts #orthopedicexperts
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MCRA experts Mehdi Kazemzadeh-Narbat, PhD, PMP, CQA and Kevin B. McGowan, PhD recently published a manuscript with other key authors entitled “Advances in antimicrobial orthopaedic devices and FDA regulatory challenges.” The manuscript outlines recent strategies for minimizing orthopaedic implant-associated infections and the associated regulatory challenges. Read the abstract and access the full manuscript on the MCRA website: https://lnkd.in/eCMNcEGG #orthopedics #medtech #medicaldevices #biologics #biotech #regulatory #FDA #FDAguidance #orthopedicimplants #antimicrobial
MCRA Experts Author New Manuscript on Antimicrobial Device FDA Challenges
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