Ready to launch your product in new healthcare markets around the world, but not sure where to start? MCRA’s Global Regulatory consultants have 80+ years of combined experience guiding clients through the regulatory submission process and interacting with Regulatory Agencies in Europe, Japan, Canada, and many more countries. Learn how MCRA can expand your global marketplace now: https://lnkd.in/eKSKhP9S #CEmark #UKCA #HealthCanada #PMDA #MHLW #MCRA #regulatorysubmission #regulatoryaffairs #MedTech #medicaldevices #globalmedtech #medtechindustry #NotifiedBodies #Shonin #RegulatoryAgencies
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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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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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MCRA’s experts can help your company navigate the complexities of Quality Assurance with ease. From product review, approval, and regulatory compliance, our expertise and insider FDA and Notified Bodies experience can help bring your device to market faster while maintaining QA requirements and ensuring uninterrupted market presence. Learn more about our Quality Assurance services here: https://lnkd.in/e-YgijJd #QualityAssurance #QA #MedTech #medicaldevices #medicalequipment #MCRA #MedtechQA #biotech
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Interested in learning more about the FDA’s new regulation for Laboratory Developed Tests (LDTs)? Join MCRA’s IVD experts on Tuesday July 16th at 10am EST for LDT vs. IVD: Adapting to the New FDA Regulations. This webinar will delve into the timeline for enforcement, the key aspects of the ruling, and how your organization can align with the new FDA requirements. https://lnkd.in/e8vFVenq James Mullally, Dan Goldstein, Julie Martel, PhD #IVD #LDT #LDTruling #FDA #FDAregulation #FDAregulatory #FDAcompliance #qualityassurance #LDTvsIVD #webinar #laboratorydevelopedtests #FDArule #IVDregulation #MCRA #FDAconsultants #biotech #biotechindustry #medtechindustry #medicaldevices
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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Chief Executive Officer at USA and International Research Inc.
2wImpressive expertise in global regulatory strategy! Excited to explore how MCRA can help navigate new healthcare markets.