Now available — LDT Support Services to Transform your LDTs into IVDs Learn more: https://lnkd.in/gkJR2Q8E
MDC Associates, Inc.
Medical Device
Beverly, Massachusetts 2,659 followers
Supporting IVD innovators with RA/QA/CRO, FDA/CE IVD Submission, Training, Go-to-Market support and more.
About us
For more than 30 years MDC has helped innovators and entrepreneurs bring In Vitro Diagnostics (IVD) and Medical Devices to market that impact the lives of millions of patients around the world, every year. Our mission is to continue to support diagnostic makers and innovators by applying our expertise in Regulatory and Clinical Affairs, Quality Systems, and Data Management to help launch new advances that promote and protect the health of our global and local communities.
- Website
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http://www.mdcassoc.com
External link for MDC Associates, Inc.
- Industry
- Medical Device
- Company size
- 11-50 employees
- Headquarters
- Beverly, Massachusetts
- Type
- Privately Held
- Founded
- 1988
- Specialties
- regulatory, diagnostics, point of care, FDA, IVDR, quality systems, CRO, clinical trials, IVD, medical device, training, CE mark, technical support, ISO, MDSAP, and Health Canada
Locations
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Primary
180 Cabot St
Beverly, Massachusetts 01915, US
Employees at MDC Associates, Inc.
Updates
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We're thrilled to formally introduce Carol Buchert as our Director of Regulatory and Quality! With over 25 years of experience in the MedTech industry, Carol has a proven track record of orchestrating the development and delivery of regulated products and IVD and medical device projects. Her exceptional leadership in quality management and regulatory affairs is already proving invaluable as we continue to support IVD makers in achieving their regulatory goals. Learn more about Carol's background here: https://lnkd.in/e_NJWAXH
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We’re so excited to host our first neighborhood networking event at our new US Headquarters this evening! Looking forward to meeting our neighbors and sharing our passion for advancing healthcare. Here’s to a great evening of networking and collaboration! #NetworkingEvent #OneMDC #HealthcareInnovation
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We’ll be at ADLM in Chicago from July 28 - Aug 1. Come visit us at Booth 5345 near the poster area and the ADLM Puppy Zone! We can’t wait to discuss how we can support your regulatory, quality, and clinical study needs. Looking forward to seeing you there! #ADLM2024 #LaboratoryMedicine #RegulatoryAffairs #QualityAssurance #ClinicalStudies
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We're excited to formally introduce Jim Reed as our Chief Commercial Officer! With over 30 years of experience in the MedTech industry, Jim has a remarkable track record of driving growth and innovation. His leadership in transforming sales organizations and developing comprehensive clinical data and reimbursement strategies will be invaluable as we continue providing IVD makers with the support and solutions they need to make our world a healthier place. Read more about Jim here: https://lnkd.in/gaQEW4j4
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The first of many likely new guidance documents on Laboratory Developed Tests (LDTs) is intended to help small entities understand the LDT final rule in plain language. 🔗 https://lnkd.in/gJp5gXAH #LDT #IVD #RegulatoryAffairs #MedicalDevices #FDA
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MDC Associates, Inc. reposted this
Thank you MDC Associates, Inc. team for helping us bring ASTar System to the U.S. market and thank you for the cookies! #FDAcleared #diagnostics #infectiousdiseases #rapidAST
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If you're scrolling right now, we're starting in just under 30 minutes. Hope to see you there! 🔗 Link: https://lnkd.in/g8YsdXE5 📅 Date: Thursday, June 20 🕒 Time: 1:00 to 2:30 PM ET #laboratory #lab #microbiology #chemistrylab #lablife #ivd #medicaldevices #ldt #fda
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We're thrilled to invite you to this new webinar, hosted in partnership with Greenlight Guru, on the evolution and current state of Laboratory Developed Tests (LDTs) following the FDA's recent final rule announcement. 📅 Date: Thursday, June 20 🕒 Time: 1:00 to 2:30 PM ET 🔗 Link: https://lnkd.in/g8YsdXE5 Join Carol Buchert, Sruthi Sundaram, PhD, RAC, and Etienne Nichols as they dive into the implications for labs transitioning their LDTs into IVDs, cover exemp devices, and discuss continued enforcement discretion. #laboratory #lab #microbiology #chemistrylab #lablife #ivd #medicaldevices #ldt #fda
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An incredible first day at #ASMMicrobe in Atlanta connecting with clients, fellow professionals, and friends, sharing insights, and discussing the latest advancements in microbiology and diagnostics. If you're attending, let us know so we can meet face to face! #ASMMicrobe2024 #MedicalDevices #IVDs #InVitroDiagnostics #HealthcareInnovation