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
MDC Associates, Inc.
Medical Device
Beverly, Massachusetts 2,487 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
Get directions
180 Cabot St
Beverly, Massachusetts 01915, US
Employees at MDC Associates, Inc.
Updates
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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
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Join us on June 20 from 1-2:30 PM ET!
BIG webinar on June 20th as experts from Greenlight Guru and MDC Associates, Inc. discuss the evolving landscape for Laboratory Developed Tests (LDTs). The session will delve into the new LDT rule, exploring its implications for laboratories to move their LDTs into the FDA regulated environment of in-vitro diagnostics (IVDs), identifying exempt devices, and discussing continued enforcement discretion. Check out the link below to save your spot: https://lnkd.in/gtKp6wF3
From LDTs to IVDs: Navigating the New Regulatory Landscape
greenlight.guru
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We're heading for ASM Microbe in Atlanta this week! Let's meet in person to discuss your IVD projects and how MDC can help. Contact Jim Reed to set a time! #ASMMicrobe #IVD #CRO #RegulatoryAffairs #QualitySystems
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"Advancing women's health through better diagnostics and testing access is a crucial effort we support." —Joen Johansen, CEO, MDC Associates “At MDC Associates, we recognize the critical importance of advancing women's health through improved diagnostics and increased access to testing, especially in rural areas. The White House Initiative on Women’s Health Research underscores the need for innovative solutions in oncology, infectious diseases, and more. We proudly support bringing new FDA-regulated IVDs and devices to market that address these vital areas.” #womenshealth #health #diagnostics #IVD #medicaldevices
Executive Order on Advancing Women’s Health Research and Innovation | The White House
whitehouse.gov