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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The Big Squeeze

Posted on March 10th, 2010

As I do my best to keep my finger on the pulse of the industry and market, here’s my assessment. I think a lot of the companies are holding on to the cash knowing there are pending FDA issues. Some of these issues have been exposed, others are known but not exposed yet. It’s a [...]

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IRS To Honor Medical Resident FICA Refund Claims

Posted on March 8th, 2010

IR-2010-25, March 2, 2010
WASHINGTON — The Internal Revenue Service has made an administrative determination to accept the position that medical residents are excepted from FICA taxes based on the student exception for tax periods ending before April 1, 2005, when new IRS regulations went into effect.
The IRS will, within 90 days, begin contacting hospitals, universities [...]

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Minnesota med tech community on possible 510(k) overhaul: ‘We’re not gonna take it …’

Posted on March 1st, 2010

By Thomas Lee

Image via Wikipedia

MINNEAPOLIS, Minnesota — “We’re not here to bash the FDA,” Mark DuVal, president of  Minneapolis law firm DuVal & Associates, told a group of medical device executives and investors late Wednesday afternoon.
Too late.
The newly formed Minnesota Medical Device Alliance billed the gathering in the downtown Warehouse District as the first step [...]

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FDA Memo Hints at Curbs to Approval Process for Medical Devices

Posted on March 1st, 2010

By ALICIA MUNDY And JARED A. FAVOLE
WASHINGTON—The Food and Drug Administration may tighten or eliminate several pathways for getting a medical device approved quickly amid concerns they have been overused by industry, according to an internal agency memo reviewed by The Wall Street Journal.
The proposals came in a Dec. 22 briefing involving officials in the [...]

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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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