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??
MCRA, an IQVIA business
医疗设备制造业
Washington，DC 11,763 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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Only one more week until “Harnessing Digital Health Data: Navigating Regulations, Clinical Trials and Reimbursement” webinar! Join Alex Cadotte, Kenneth Rayl and Michael Anselmo of MCRA as they share the winning strategies for regulatory, reimbursement, and clinical trials when it comes to Digital Health.? ? Register now: https://lnkd.in/eVaAun26?? ? #digitalhealth #webinar #MCRA #regulatory #FDA #clinicaltrials #reimbursement #FDAapprovaal #FDAclearance #SAMD #SIMD #AIML??
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MCRA’s Reimbursement, Health Economics & Market Access (RHEMA) services take a creative and proactive approach to ensure Patient Access, integrating a variety of service offerings.? ? Our Patient Access approach integrates technology specific coding support and education, case specific benefits verification, pre-authorization support, appeals for payer denials, payor outreach alternatives, field reimbursement support and more to ensure patients in need have the best pathway to use and obtain your medical innovation.?? ? Learn more about our Reimbursement, Health Economics & Market Access services: https://lnkd.in/eFjJ7imV? ? #reimbursement #MedTech #medicaldevices #marketaccess #healthcareeconomics #healthcareindustry #medtechindustry #medtechinnovation #reimbursementstrategy #MCRA #patientaccess??
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Senior Associate, Talent Acquisition at MCRA | AIRS Certified Diversity Recruiter (CDR)
MCRA, an IQVIA business is thrilled to announce that we are recruiting for our 2025 Summer Internship Program! We are looking for 8 talented interns to join our Business Development, Clinical Affairs, Compliance, Regulatory and Reimbursement, Health Economics, and Market Access (RHEMA) teams. Program Details: ?? Duration: June 2, 2025 – July 25, 2025 ?? Schedule: Monday – Friday, 9 AM – 3 PM ?? Location: Hybrid | Washington, DC office This is a fantastic opportunity to gain valuable industry experience, work with a dynamic team, and expand your professional network. Interested? Apply today! https://lnkd.in/ed8F3s9j
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Watch our latest webinar, FDA Layoffs and the Impact to Industry, now! MCRA's former FDA leaders discuss the recent changes at FDA, how to de-risk your medical device, and strategies to achieve success moving forward. #FDA #FDAconsultants #FDAclearance #FDAapproval #MedTech #Biotech #medicaldevices #regulatoryaffairs #clinicalffairs #biocompatibility
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Meet MCRA: Robert Allen, PhD, Director, Regulatory Affairs - Biocompatibility?? ?? Robert A. Allen, PhD is a former FDA medical device reviewer and biocompatibility expert with extensive experience in biological evaluation, hemocompatibility, and 9 years of experience in regulatory affairs. Dr. Allen has worked on a wide variety of medical device types including cardiovascular, neurological, orthopedic, and plastic/reconstructive surgery.??? ?? Before joining MCRA, Dr. Allen spent 3 years at FDA in the Center for Devices and Radiological Health (CDRH). During that time, he spent 2 years as a lead reviewer and biocompatibility reviewer in the Division of Cardiovascular Devices, now known as OHT2, evaluating vascular and endovascular devices. Dr. Allen also served as an AIMBE Scholar at FDA, focusing on strategic projects for the Office of Device Evaluation, now known as OPEQ. #MCRA #MeetMCRA #medtechindustry #medtechinnovation #medtech #regulatoryaffairs #regulatory #USregulatory #FDA #FDAapproval #medicalinnovation #medicaldevice #medicaldevices #innovation #biocompatibility #toxicology?
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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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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?
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