We're pleased to introduce Jeff Button, the Director of our Project Management Office. With over 20 years in the pharma and medical device industries, Jeff's expertise in program management and project execution is already making a difference for our clients. Check out his full profile here: https://lnkd.in/gePsYuzh #OneMDC #ProgramManagement #IVD #MedicalDevices #RegulatoryCompliance #QualityAssurance
MDC Associates, Inc.
Medical Equipment Manufacturing
Beverly, Massachusetts 2,832 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 Equipment Manufacturing
- 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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MDC Associates, Inc. reposted this
Excited to speak at Next Gen Dx Summit on Aug 19, 2pm ET! Join me in person or virtually—there's still time to register. Don’t miss it! #NextGenDx
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MDC Associates, Inc. reposted this
On Tuesday, September 24, the FDA will host a webinar on labeling requirements for In Vitro Diagnostic Products (IVDs), including LDTs. The focus of this webinar will be on labeling requirements for test systems, under 21 CFR 809.10(b). All questions must be received by August 23, 2024, to be considered for the discussion. Questions will be not be taken during the live webinar. Learn more: https://lnkd.in/eJbtn4y2
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🖐 Meet Shiraz Khun Haron, one of the incredible Clinical Research Associates at MDC Associates! With over 13 years of experience and a PhD in Medical Sciences, Shiraz brings a wealth of knowledge and a true passion for improving healthcare. Before joining MDC, Shiraz supported medical devices at a global contract research organization and led quality assurance for genetic research in a hospital and university setting. Since joining us last year, Shiraz has been instrumental in ensuring our clinical research projects run smoothly and stay on track with all those important regulations. Her expertise and dedication have already made a big impact on our team. We’re so fortunate to have her with us and can’t wait to see what she’ll continue to accomplish! #TeamMDC #ClinicalResearch #MeetTheTeam #HealthcareInnovation
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💲 FDA recently updated user fees for FY 2025 under MDUFA V. Get the highlights from Audrey Skeen on IVDwise. If you haven't yet, subscribe to IVDwise for Regulatory, Quality, and Clinical Insights for IVDs. #FDA #IVD #MedicalDevices #RegulatoryAffairs #CRO #IVDwise
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📢 Over the past six months, 4️⃣ new options for rapid AST directly from blood culture have received FDA clearance. #IVDwise #AST #AntibioticResistance
Four New Rapid AST Solutions Hit the Market over Six Months
https://www.mdcassoc.com
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Check out the energy here at #ADLM booth 5345! 🐶 Simply adorable. Stop by to visit the puppies, stay for LDT, IVD, and CRO insights! #ADLM2024 #IVD #MedicalDevices #CRO #QualitySystems #RegulatoryAffairs
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📸 Live from ADLM 2024! An action packed opening of the Clinical Lab Expo! It’s been fantastic to connect with industry leaders and share the latest across the clinical, quality, and regulatory spectrum for medical devices and IVDs. Find us at booth 5345 near the posters and puppies! #ADLM #IVD #MedicalDevices
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Sound strategy and the support to execute it. Visit us at ADLM Booth 5345 and let's talk about your projects. #ADLM #IVD #FDA #MedicalDevices
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We're packing up for #ADLM and have some advice for you: Bring an ☂! See you at Booth 5345 near the posters and puppies! #Chicago #MedicalDevices #IVD Forecast as of 1:50pm CDT and is subject to change. 😄
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