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
So happy for you and Q. It has been a long road. Congrats. Cindy
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. 😄
Now available — LDT Support Services to Transform your LDTs into IVDs Learn more: https://lnkd.in/gkJR2Q8E
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
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
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
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
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
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
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
It's a team effort and takes the contribution of many dedicated and hard working individuals across companies, clinical sites and of course also the FDA to bring this platform to the US market. Congratulations again to the Q-linea team and continued best of good luck in commercializing ASTar and supporting the fight against antimicrobial resistance. #rapidAST