Welcome to Medpoint

Welcome to Medpoint, LLC, a leading domestic and international consulting firm for Quality Assurance, Regulatory and Clinical Affairs. We have over 100 of the most highly qualified consultants working all levels of projects in Medical Device, Biotech, and Pharmaceutical in over 90 countries.

Our clients span the spectrum from start-up to Fortune 20 and look to us for short-term or long-term expertise in the following areas:

  • FDA Guidance
  • CAPA’s
  • Quality System Regulations
  • IS0 13485
  • QMS Audits
  • European CE Marking
  • Technical Files
  • 510 (k)/IDE/PMA/ANDA/NDA Approvals
  • STED
  • Japan PAL
  • China SFDA
  • Sterilizations
  • Canadian Licenses
  • Internal and Supplier Audits
  • FDA Mock Audits
  • 483 & Warning Letter Responses
  • IVD
  • Biologics
  • Blood and Blood Products
  • Clinical Trial Strategy/Monitoring
  • ISO 14971
  • Validations
  • Design Control
  • Risk Analysis & Management
  • DHF Development
  • CMDCAS
  • GMP
  • Resolving Consent Decrees
  • Global Regulatory Strategies
  • Drug Listing, Registration, and Master Files

Medpoint Weblog

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Boston Scientific Lands FDA Approval for Next-Gen Heart Devices

Posted on April 17th, 2014

Written by: Arezu Sarvestani Boston Scientific gets the FDA’s OK for a new generation of defibrillators and heart failure devices, including some of the world’s smallest and thinnest ICDs. Boston Scientific (NYSE:BSX) announced this week that it won FDA approval for its newest suite of cardiac devices, including next-generation defibrillators and heart failure devices. The newly approved […]

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Medicrea Launches UNiD Patient-Specific Spinal Rod in Europe

Posted on April 17th, 2014

Written by: Lena Freund French devicemaker Medicrea announced the launch of its UNiD patient-specific osteosynthesis spinal rod system in Europe. The system allows surgeons to contour the device to a patient’s unique spinal anatomy prior to surgery and get a custom-made rod for implant. Typically, such contouring requires a manual rod-bending device, which can leave […]

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FDA Clears Covidien’s Kangaroo Feeding Tube With IRIS Technology

Posted on April 16th, 2014

Written by: Lena Freund Covidien is launching its Kangaroo feeding tubes with IRIS technology immediately in the U.S., following the receipt of FDA 510(k) clearance. The device consists of a disposable tube with a 3-mm camera that streams real-time video of a patient’s anatomy back to a monitor. The camera allows physicians to be sure […]

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Abbott Completes Enrollment in U.S., China, Japan Absorb Trials

Posted on April 15th, 2014

Written by: Lena Freund Enrollment is complete in U.S., Chinese and Japanese trials of Abbott’s everolimus-eluting Absorb bioresorbable vascular scaffold, the Illinois drugmaker said. The studies will compare the effectiveness of Absorb versus Abbott’s drug-eluting Xience stents in opening blocked heart vessels. The trials involve a total of 2,800 coronary artery disease patients: 2,000 in […]

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FDA Clears GE Healthcare’s Q.Clear Technology

Posted on April 10th, 2014

Written by: Lena Freund GE Healthcare plans to roll out its Q.Clear imaging technology in the U.S. over the next several months, following 510(k) clearance by the FDA. The device provides up to twice the improvement in accuracy and image quality in PET and CT imaging, the company says. Q.Clear combines hardware and software to […]

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