What makes MCRA the industry leader in Breakthrough Device Designations? MCRA’s experts have been successful in obtaining more than 100 Breakthrough Device Designations for client’s medical technology— the best track record in the industry. Breakthrough Devices must meet the FDA’s rigorous standards for device safety and effectiveness for marketing authorization. Although guiding a new product through this painstaking process is difficult, MCRA’s consultants have a deep understanding of its intricacies and help our clients get to market quickly and safely. Learn more about our Breakthrough Device experience: https://lnkd.in/eCvcANau #MCRA #medtechindustry #medtechinnovation #medtech #medicalinnovation #medicaldevice #medicaldevices #innovation #BreakthroughDeviceDesignation #FDAClearance #regulatoryaffairs #regulatory #USregulatory #FDA #FDAapproval
MCRA, an IQVIA business
医疗设备制造业
Washington，DC 10,961 位关注者
Leading Global Full-Service Medical Device, Diagnostics & Biologics CRO & Integrated Consulting Advisory Firm.
关于我们
MCRA, an IQVIA business, is the leading global full-service medical device, diagnostics, and biologics CRO and consulting advisory firm. MCRA delivers to its client’s industry experience, integrating its seven business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, due diligence and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, London, England, Winterthur, Switzerland, Eschborn, Germany and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices and medical device cybersecurity. MCRA places particular emphasis on its expertise working with companies in all stages of development and throughout the technology life cycle by ushering technologies from the conceptual pre-clinical stage to market approval.
- 网站
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https://www.mcra.com
MCRA, an IQVIA business的外部链接
- 所属行业
- 医疗设备制造业
- 规模
- 51-200 人
- 总部
- Washington，DC
- 类型
- 私人持股
- 创立
- 2004
- 领域
- Clinical Affairs、Quality Assurance、Regulatory Affairs、Reimbursement、Healthcare Compliance、clinical research、CRO、Orthopedic Devices、Biologics、Cardiovascular Devices、Spine、Spine Devices、Wound Care Devices、Dermatology Devices、Combination Devices、Neurology Devices、Digital Health、General & Plastic Surgery、Dental Devices、Electrophysiology、Combination Products、Opthalmology、Neuro-Musculoskeletal、Diagnostics、In-Vitro Diagnostics、Healthcare Compliance、Cybersecurity、Critical Care Devices、CE Marking、DMAH Services、Imaging、Market Access、Clinical Testing、Clinical Evaluations、Artificial Intelligence和Machine Learning
地点
MCRA, an IQVIA business员工
动态
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Evaluating biocompatibility in medical products involves a time-intensive comprehensive risk management process, which starts with examining materials, manufacturing procedures, geometry, surface properties, and the type and duration of patient contact. The next steps are testing, if needed, and risk assessment, which can be time-consuming and resource-intensive. With MCRA’s streamlined biocompatibility services, we eliminate unnecessary testing while identifying and mitigating risks, saving time, achieving regulatory compliance and strengthening your market position.? Learn more about our biocompatibility services: https://lnkd.in/ezA5zGxa #biocompatibility #toxicology #MCRA #medtech #regulatoryaffairs #regulatory #USregulatory #FDA #FDAapprovalh #MedTech #medicalinnovation #medtechindustry #medicaldevice???
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MCRA’s Regulatory and Biocompatibility teams successfully worked together with Onkos Surgical to garner the first FDA De Novo approval for Onkos’ antibacterial coating for implants. Read our case study to learn more about how MCRA’s integrated expertise can aid your medical device throughout the product lifecycle. Connect with our Regulatory Team:?https://lnkd.in/e8ty2tEK ? #biocompatibility #MCRA #medtech #regulatoryaffairs #regulatory #USregulatory #FDA #FDAapproval #medicalinnovation #medicaldevice #medicaldevices #Orthopaedics #Orthopedics #orthopedicimplants #orthopedicdevice #orthodevice #orthoexperts #orthopedicexperts #orthopedictechnology #casestudy?
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Meet MCRA’s AI & Imaging Center and Digital Health teams at RSNA Booth #5560 from December 1st to December 5th in Chicago!? ? Our team is happy to discuss your upcoming projects and how our team can set your company up for success. Contact us at [email protected] for more information.?? ? #RSNA #RSNA2024 #MCRA #AI #Imaging #DigitalHealth #medicaldevice #medicaldevices #Radiology #RadiologicalSociety #medtech?? ??
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MCRA is proud to have supported IceCure Medical during their recent Advisory Committee Panel Meeting, where their ProSense? cryoablation system was reviewed for the treatment of early-stage, low-risk breast cancer. Our team of experts assisted in preparing IceCure for the panel, and Margeaux Rogers, MCRA’s Vice President of Regulatory Affairs, presented on behalf of IceCure and also served as the meeting’s moderator. We are pleased with the outcome, as the majority of panel members voted in favor that the benefits of the ProSense? Cryoablation system outweigh its risks for the proposed indication. We are excited to see this innovative technology continue its regulatory journey as IceCure works towards marketing authorization for this treatment option. #MCRA #FDA #FDAconsultants #regulatoryaffairs #regulatory #medtech #medicaldevices #advisorypanel #breastcancer #cancertechnology #medtechinnovation #clinicaltrial #clinicalstudy
FDA Advisory Panel Votes in Favor of IceCure Medical’s ProSense? Cryoablation Benefit-Risk Profile in Early-Stage Low Risk Breast Cancer FDA decision on marketing authorization expected in the first quarter of 2025 The FDA panel’s favorable vote?is a significant milestone on the path towards the marketing authorization of ProSense? #cryoablation in the U.S. for early-stage low risk #breastcancer with adjuvant endocrine therapy. Read the full #pressrelease here: https://lnkd.in/eWDy7q8N IceCure would like to thank the FDA, all of the panelists, and those who helped support us in this process, including our regulatory and clinical teams, and the physicians and patients who participated in the panel. Shay Levav Maayan Kahlon- Levi Hilla Debby Ronit Lipson Rotem E. Stav Edgar Margeaux Rogers Nathalie Johnson Richard Fine Robert C. Ward, M.D. Kenneth Tomkovich MD Muriel Smith Eyal Shamir Ronen Tsimerman Tlalit Bussi Tel-Tzure Naum Muchnik Merav Nir Dotan Galit (Bar) Malik Shad Good #investorrelations $ICCM
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The complexity in developing new wound care technologies, both in the US and global markets, can hinder a company's timeline to market. As regulations shift, it is important to work with a team who understands the requirements of key stakeholders to ensure the successful commercialization of wound care products. MCRA’s integrated regulatory, clinical, and reimbursement experts work with with our medical device, biologics, and regenerative medicine wound care clients to provide value throughout the product lifecycle. Learn more about our Wound Care services: https://lnkd.in/euhAYCMr #MCRA #woundcare #woundhealing #woundmanagement #woundcareinnovation #woundcaredevice #medtech #medicaldevice #medicaldevices
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Insights Care magazine is pleased to feature Hassan F. Abdallah JD, CHC, Head of Compliance at MCRA, an IQVIA business. Abdallah has become a respected figure in the industry through his unique approach to compliance, which is marked by strategic thinking and a focus on innovation. Read More: https://cutt.ly/yeHNG7Y4 #PurposeDrivenLeadership #ComplianceStrategies #HealthcareLeadership #InnovativeLeadership #InsightsCare #onlinehealthcaremagazine #globalhealthcaremagazines
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Maximizing the value of your healthcare innovation is our priority. The MCRA Integrated Approach offers bespoke product pathways and strategies informed by the entirety of the commercialization process. Combined with our specialized therapeutic expertise, we help clients navigate the complexities of healthcare innovations and achieve success. ? ? Learn more about our services and therapy specializations: https://www.mcra.com/? ? #MCRA #medicaldevices #medtech #biotech #CRO #clinicalresearchorganization #clinicaltrials #healthcare #therapyspecialization #medtechdevices #regulatory #regulatoryaffairs #FDAconsultants #fda #FDAapproval? ?
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MCRA’s Digital Health services are built upon our expert MedTech industry knowledge that encompasses every aspect of the product lifecycle. We help the most cutting-edge companies seamlessly enter the MedTech market. From providing CRO expertise to digital health policy navigation and more, our team strategizes to prepare your company for the best outcomes efficiently. Learn more about our Digital Health services: https://lnkd.in/e3eAy6Uj #DigitalHealth #MCRA #medicaldevices #medicaldevice #MedTech #HealthTechnology #regulatory #CRO #AIML #AI #ML #artificialintelligence #machinelearning #aitechnology #digitaltechnology #healthcare #FDA #FDAconsulting #FDAconsultant #FDAapproval #regulatoryaffairs #clinicalstudy #clinicaltrial
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