Welcome to Medpoint

Welcome to Medpoint, LLC, a leading domestic and international consulting firm for Quality Assurance, Regulatory and Clinical Affairs. We have over 50 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 settles Johnson & Johnson stent patent spat for $1.7 billion

Posted on February 8th, 2010

Boston Scientific Corp. (NYSE:BSX) will pay Johnson & Johnson (NYSE:JNJ) $1.725 billion to settle a quartet of patent infringement lawsuits concerning the companies’ lines of cardiovascular stents.
The Natick, Mass.-based medical devices monolith agreed to the settlement, which calls for it to pay J&J $1 billion today and the rest in about a year, said it [...]

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Medtronic Receives FDA Approval for First Replacement Heart Valve Implanted Without Surgery

Posted on February 4th, 2010

In a significant development for congenital heart disease patients, Medtronic, Inc. (NYSE: MDT), announced today that its Melody® Transcatheter Pulmonary Valve has received U.S. Food and Drug Administration (FDA) approval under a Humanitarian Device Exemption (HDE). This innovative medical device is the first transcatheter heart valve to receive FDA approval.
Delivered through a catheter requiring only [...]

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FDA asks for 23 percent budget boost

Posted on February 4th, 2010

The Food & Drug Administration is asking Congress to foot its $4.03 billion bill to overhaul its own operations and increase its scrutiny of the medical device, pharmaceutical, food and tobacco industries.
As it lays out its ambitious plans for fiscal 2011 and beyond, the federal watchdog agency wants a 23 percent boost to its annual [...]

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Diagnostic Hybrids Announces FDA Clearance Of D3(R) FastPointTM L-DFATM RSV/MPV Identification Kit

Posted on January 18th, 2010

Diagnostic Hybrids, a leading developer of in vitro diagnostic fluorescent staining kits and cell culture products, announces the U.S. Food and Drug Administration (FDA) (510k) clearance of its D3 FastPointTM L-DFATM RSV/MPV Identification Kit, which allows for the identification of respiratory syncytial virus and human metapneumovirus from a patient’s specimen in under 25 minutes. The [...]

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Startup At UCLA Tech Incubator To Begin Clinical Trials For Wireless Body-Monitoring System

Posted on January 18th, 2010

MediSens Wireless, a startup company in UCLA’s on-campus technology incubator at the California NanoSystems Institute, has obtained approval under federal Food and Drug Administration guidelines to begin clinical trials on its novel wireless body-monitoring system, which assesses muscle and neuromotor functions in the upper extremities.
The Clinical Movement Assessment System (CMAS) is designed for a wide [...]

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