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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Bill on Medical Devices’ Quality Proposed

Posted on June 10th, 2014

Written by: Azuhaar Abdul Azeez, Haveeru Online, June 10, 2014 A bill regarding the maintenance of the standard, quality and safety of the devices and equipments that are used in the health industry has been submitted to the parliament. Proposed by Holhudhoo MP Ali Mohamed, the bill specifies a criterion to determine the safety standards […]

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Global Medical Device Regulation Changes: A Perfect Storm?

Posted on May 7th, 2014

Released: 05/05/2014 14:34:00 Source: http://www.packagingeurope.com/Packaging-Europe-News/58485/Global-Medical-Device-Regulation-Changes-A-Perfect-Storm.html The medical devices sector plays a crucial role in the diagnosis, prevention, monitoring, and treatment of diseases and in improving the quality of life of disabled people. As a result, it’s a market subject to some of the most stringent and extensive legislation on the planet. What this legislation is […]

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FDA Approves Implantable Device for Hard-to-Treat Sleep Apnea Sufferers

Posted on May 5th, 2014

Written by: Meg Bryant Inspire Medical Systems said Thursday that the FDA has approved its Inspire upper airway stimulation device for patients with moderate to severe obstructive sleep apnea who are unable to use continuous positive airway pressure. The company plans to launch the device — the first of its kind for obstructive sleep apnea […]

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BSX Rolls Out Promus Premier Coronary Stent in Japan

Posted on May 2nd, 2014

Written by: Meg Bryant Boston Scientific has launched its next-generation Promus Premier everolimus-eluting platinum chromium coronary stent system in Japan, following approval by the Ministry of Health, Labor and Welfare. The device features “unparalleled visibility and low recoil, plus exceptional radial strength and fracture resistance,” the company said Thursday. “An enhanced low-profile delivery system is […]

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FDA Eyes Fast-Track Approval for Urgently Needed Medical Devices

Posted on May 1st, 2014

Written by: Eric Wicklund – Editor, mHealthNews (April 28, 2014) inShare The U.S. Food and Drug Administration is looking to expedite the approval process for medical devices that would help patients whose urgent healthcare needs aren’t met by current technology. The move follows recent criticism that FDA oversight of mHealth devices and systems would hinder […]

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