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
  • Quality System Regulations
  • IS0 13485
  • QMS Audits
  • European CE Marking
  • Technical Files
  • 510 (k)/PMA/ANDA/NDA Approvals
  • STED
  • Japan PAL
  • China SFDA
  • Canadian Licenses
  • Internal and Supplier Audits
  • 483 & Warning Letter Responses
  • IVD
  • Clinical Trial Strategy
  • ISO 14971
  • Validations
  • Design Control
  • Risk Analysis & Management
  • DHF Development
  • CMDCAS
  • GMP

Medpoint Weblog

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Teleflex Has Received Clearance

Posted on October 29th, 2008

October 12

RESEARCH TRIANGLE PARK, NC — Teleflex Medical, a leading global supplier of disposable products for critical care and surgical applications, has received clearance from the FDA to market the Hudson RCI Neb-U-Mask®, a respiratory device that allows for the concurrent delivery of aerosolized medication and a high concentration of medical gases to treat acute asthma exacerbations. Continue reading »

FDA Licenses for Marketing New Therapy

Posted on October 29th, 2008

October 12

The U.S. Food and Drug Administration today licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States.  The product, called Cinryze, is licensed for the prevention of HAE attacks, which can occur spontaneously or during stress, surgery, or infection in patients diagnosed with the disease. Attacks can produce rapid swelling of the hands, feet, limbs, face, intestinal tract or airway. Swelling of the larynx can lead to asphyxiation. Continue reading »

Boston Scientific Announces Schedule

Posted on October 24th, 2008

October 10

PRNewswire-FirstCall/ — Boston Scientific Corporation (NYSE: BSX) today announced the schedule of the Company’s major events and press announcements at the Cardiovascular Research Foundation’s (CRF) twentieth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, which runs from October 12 to 17 in Washington, D.C.

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