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:

  • ISO 9001
  • ISO 13485
  • ISO14971
  • 21 CFR 820 / 210 / 211
  • Part 11
  • GMP / GDP / GLP / GCP
  • CE Marking
  • CMDR
  • JPAL
  • EU MDD
  • 510(k) / IDE / PMA / ANDA / NDA
  • Technical Files
  • Global Regulatory Strategies
  • Clinical Trial Strategy / Monitoring
  • Validations
  • Design Control
  • Master Files
  • Clinical Strategic Support
  • IVD
  • FDA Mock Audits
  • 483 & Warning Letter Responses
  • Resolving Consent Decrees
  • FDA Guidance
  • Internal & Supplier Audits
  • CAPAs
  • Training
  • MS Audits
  • Medical Writing
  • Supplier Development
  • Sterilization Strategic Support and Advisement
  • Permanent Placement
  • Biologics
  • Blood & Blood Products
  • DFH Development
  • Drug Listing Registration & Master Files

Medpoint Weblog


Medical Device Recalls Rise 27 Percent in Fourth Quarter

Posted on May 6th, 2015

Source: http://www.fdanews.com/articles/170852-medical-device-recalls-rise-27-percent-in-fourth-quarter “The number of medical devices recalled in the U.S. during the final quarter of 2014 increased over the previous quarter despite an overall drop in the number of recall actions, a report from Stericycle Expert Solutions shows. Overall, 23.8 million devices were affected by recall actions during the quarter, up 27 percent from […]

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DePuy Pairs Knee Implant System with Blue Belt’s Surgical Robo

Posted on September 19th, 2014

Written by Kellen Owings Blue Belt Technologies has inked an agreement to support DePuy Synthes’ SIGMA HP partial knee system with Blue Belt’s Navio robotic surgical system. This is the sixth implant system supported on Navio’s open platform software, the Minneapolis devicemaker said. The Navio system offers CT-free navigation software and a hand-held computer-controlled bone […]

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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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