MCRA is pleased to announce its role in the U.S. Food and Drug Administration’s (FDA) 510(k) clearance for 3D Systems’ 3D-printed, patient-specific cranial implant solution — VSP® PEEK Cranial Implant. MCRA’s biocompatibility team worked with 3D Systems to design and execute a biocompatibility strategy, including chemical characterization studies, that addressed FDA expectations and demonstrated that the device is biocompatible for patient use. The VSP PEEK Cranial Implant is now the world's first patient-specific and 3D-printed PEEK cranial implant using an extrusion platform to receive such clearance. Read the full press release here: https://lnkd.in/eYaVzHP3 #pressrelease #MCRA #biocompatibility #FDA #FDAapproval #FDAclearance #510k #FDAsubmission #cranialimplant #neurology #neurodevice #medtech #biotech #medicaldevices #medtechinnovation #medtechindustry
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Join James Mullally, Dan Goldstein, and Julie Martel, PhD, MCRA’s expert IVD Team on Tuesday July 16th at 10am EST for our webinar, LDT vs. IVD: Adapting to the New FDA Regulations. Learn about 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. Register now: https://lnkd.in/e8vFVenq #IVD #LDT #LDTruling #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
mcra.com
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Healthcare innovators typically design their trials with safety and effectiveness, regulatory approval and robust data in mind. However, they often neglect the necessity of a sound reimbursement strategy. MCRA’s Life Sciences Advisory Panel (LSEAP) offers valuable stakeholder feedback to accelerate market adoption. We also provide a detailed foundational assessment of current payer coverage, as well as coding and payment policies to help you identify the most strategic reimbursement pathway for successful commercialization of your innovation #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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One week away! Don’t miss MCRA’s IVD Experts James Mullally, Dan Goldstein, and Julie Martel, PhD for our webinar LDT vs. IVD: Adapting to the New FDA Regulations. Join us on Tuesday July 16th at 10am EST, as they 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. Register here: https://lnkd.in/e8vFVenq #IVD #LDT #LDTruling #FDA #FDAregulation #FDAregulatory #FDAcompliance #qualityassurance #LDTvsIVD #webinar #laboratorydevelopedtests #FDArule #IVDregulation #MCRA
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Meet MCRA: Nicholas Giokas, Director of Spine Clinical Affairs & Safety Lead Nick Giokas oversees both the Spine CRO division & Safety Committees at MCRA. He has been with the firm since 2018. Nick has led studies in both cervical and lumbar indications, both in motion sparring and fusion devices. As the Safety Lead at MCRA, Nick was the chief strategist in the design of the MCRA procedures for safety committee management and leads recruiting efforts for safety committee physicians. He has also designed and managed multiple Clinical Events Committees, Data Safety Monitoring Boards, and Protocol Advisory Committees across several different indications (Spine, Neurology, Orthopedics, Wound Care). Prior to joining MCRA, worked on the clinical operations team with a mid-sized sponsor. The pipeline he worked on included multiple global phase III pharmaceutical IND studies. The studies included both adult and pediatric patient populations and spanned across the US, Canada, and EU. Learn more about Nick Giokas now: https://lnkd.in/eJFTWJz4
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Recruiting and training clinical trial staff is a costly and time-consuming process. MCRA has a ready pool of sites and experts, saving you the expenses associated with recruitment and onboarding. MCRA’s contracting team has worked with hundreds of sites and institutions across the globe. We leverage our extensive experience and relationships to streamline the process of implementing clinical trials for our clients — saving them significant time and money. #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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The diverse nature of wounds makes their treatments complex and ever-changing. Count on MCRA’s expert dermatology and wound care consultants to help ensure an effective product life cycle from concept to market. Learn more about the services we offer for wound care, dermatology and biologics at out website: https://lnkd.in/euhAYCMr #woundcare #woundhealing #woundmanagement #woundcareinnovation #woundcaredevice
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MCRA’s Cardio and Biocompatibility Regulatory teams are proud to have supported Xeltis with their IDE submission. #IDE #FDAapproval #FDAguidance #FDAsubmission #cardio #medtech #medicaldevices
Today, Xeltis announces that the FDA has approved an Investigational Device Exemption (IDE) submission to begin enrolling patients in a pivotal study for #aXess. This US-based pivotal trial follows strong 12-month data from a first-in-human study in Europe and marks a significant milestone in the company's clinical strategy. aXess is a restorative conduit that allows the formation of a new living vessel for hemodialysis vascular access, providing a better dialysis patient experience. To learn more about the aXess US pivotal trial, see the press release in the comments section below. #FDA #VascularAccess #IDE
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Chief Executive Officer at USA and International Research Inc.
3wFantastic achievement! Congratulations to MCRA and 3D Systems on this groundbreaking FDA clearance for the VSP® PEEK Cranial Implant. #medtech #FDAapproval