Join MCRA’s experts as they discuss the recent changes at FDA and how this may impact your MedTech process. This panel discussion will feature former FDA leaders, sharing their insights and expertise to help you achieve long-term success.?? ? Register now for this upcoming webinar!?? https://lnkd.in/eNgm7fHc? ? #webinar #FDA #FDAchanges #FDAapproval #MCRA #FDAexperts #FDAleaders #medtech #medicaldevices #regulatory #regulatoryaffairs #AIML #AIdevice #biocompatibility?
MCRA, an IQVIA business
医疗设备制造业
Washington，DC 11,702 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 a leading full-service medical device, diagnostics, and biologics CRO and consulting advisory firm helping global healthcare companies maximize the value of their innovations. Using an integrated approach informed by the entirety of the commercialization process, we propel healthcare innovations in all stages of development through the product pathway. MCRA offers Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, Quality Assurance, Due Diligence, AI & Imaging, Digital Health, Talent Solutions, and Cybersecurity services. Our exceptional team includes 25+ former FDA officials, payer medical directors, industry veterans, and partners from the world’s most respected medical institutions. We have extensive expertise in the therapeutic areas of orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, in vitro diagnostic (IVD) devices, regenerative medicine and more. At MCRA, we work at the speed of science, and our world-class expertise unlocks multiple barriers to success. To learn more, visit mcra.com.
- 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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Join MCRA’s Digital Health experts on March 26th for this must-watch webinar, “Harnessing Digital Health Data: Navigating Regulations, Clinical Trials and Reimbursement”. Alex Cadotte, Kenneth Rayl and Michael Anselmo will discuss key strategies in managing digital health data, focusing on regulatory compliance, reimbursement, and clinical trials.? ? Register now: https://lnkd.in/eVaAun26?? ? #digitalhealth #webinar #MCRA #regulatory #FDA #clinicaltrials #reimbursement #FDAapprovaal #FDAclearance #SAMD #SIMD #AIML??
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Congratulations to VISIE Inc. on winning this year's OrthoPitch competition! All of the contestants shared exciting and innovative products. MCRA is proud to be a foundational sponsor of OrthoPitch. Meet our regulatory, clinical and reimbursement teams at Booth #1329 at #AAOS2025!
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Connect with MCRA at LSI USA next week in Dana Point, California.?? ? Our regulatory, clinical and reimbursement experts will be happy to discuss your MedTech product needs and how MCRA’s tailored solutions can help your company achieve success.?? ? Contact us for more information and to set up an appointment: [email protected].?? ? #MCRA #LSIUSA #LSIUSA2025 #LSI #lifescienceintelligence #medtechindustry #medtechinnovation #medtech #medicalinnovation #medicaldevice? #innovation?
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Register now for our upcoming webinar, FDA Layoffs and the Impact to Industry! MCRA’s regulatory experts will share their insight on impacts to specific OPEQ review teams and OSEL technical areas as well as how they expect these changes will impact industry moving forward.?? ? The webinar will be held on March 17th – register now!?? https://lnkd.in/eNgm7fHc? ? #webinar #FDA #FDAchanges #FDAapproval #MCRA #FDAexperts #FDAleaders #medtech #medicaldevices #regulatory #regulatoryaffairs #AIML #AIdevice #biocompatibility Margeaux Rogers Alex Cadotte Devjani Saha Eric Sussman
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MCRA is excited to support the European Commission through their new pilot initiative for sponsors to submit a SINGLE application for upcoming clinical investigation or performance studies, allowing sponsors to experience a streamlined administrative process. If you are planning a FIH or looking to conduct a global pivotal trial, MCRA would be happy to partner with you through the application process. The deadline to submit is June 30th, 2025. We are looking forward to making history together. https://lnkd.in/da4WURZd #MCRA #globalregulatory #MedTech #globalregulation #Europe #EuropeanMedTech #medicalinnovation #EuropeanCommission #MDR #NotifiedBody #UK #UKMDR #medtechindustry #regulatory #regulatoryaffairs #medicaldevice
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MCRA’s biocompatibility and toxicology experts will be attending the Society of Toxicology (SOT) Annual Meeting next week from March 16th-20th in Orlando, FL.?Stop by their poster presentation on Wednesday, March 19th from 9:15am – 11:45am to learn about a “Framework for Improving Safety Assessments of Gas Pathway Devices” (Abstract #4405, Poster Board D240). ? Contact us to schedule a meeting and see how MCRA can support your company in optimizing your success for your biocompatibility needs and beyond?[email protected]. ? #MCRA #toxicology #toxicologyexperts #biocompatibility #medtechindustry #medtechinnovation #medtech #medicalinnovation #medicaldevice #innovation #biotech #riskmanagement #chemicaltoxicity #globalbiocompatibility #biologicalsafety #biosafety #bioengineering ?
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Join us next Tuesday, March 11th at 5:30 pm for OrthoPitch at AAOS 2025! Watch the finalists present their orthopedic innovations and see who the panel of judges picks as the winner!? ? OrthoPitch is an exciting technology competition for novel and innovative orthopedic products, presented by AAOS and foundational sponsor MCRA, an IQVIA business.? ? Learn more: https://lnkd.in/gizdm8aN? ? #AAOS2025 #AAOS? #OrthoPitch? #Orthopaedics? #Orthopedics? #MCRA? #orthopedicimplants?#orthopedicdevice? #orthodevice? #orthoexperts? #orthopedicexperts?
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Register now for the upcoming webinar “Harnessing Digital Health Data: Navigating Regulations, Clinical Trials and Reimbursement” on March 26th! Led by MCRA’s Digital Health experts, including Alex Cadotte, Kenneth Rayl and Michael Anselmo, the webinar will review best practices for managing digital health data, focusing on regulatory, reimbursement, and clinical trials.? ? Register today: https://lnkd.in/eVaAun26?? ? #digitalhealth #webinar #MCRA #regulatory #FDA #clinicaltrials #reimbursement #FDAapprovaal #FDAclearance #SAMD #SIMD #AIML??
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Harness the power of digital health data to advance patient care. Join our webinar to explore strategies for regulatory compliance, clinical trials and reimbursement. Learn from experts about FDA guidelines, AI best practices, and securing reimbursement for digital health solutions. Register today! https://lnkd.in/dxedxWbp #ClinicalTrials?#RegulatoryCompliance #DigitalHealthData