Medpoint

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

American Association Of Physicists 52nd Annual Meeting, Philadelphia, Pa., July 18-22, 2010 Preliminary Highlights

Posted on July 12th, 2010

At the 52nd meeting of the American Association of Physicists in MedicineAmerican Association of Physicists in Medicine (AAPM), which convenes from July 18 – 22, 2010 in Philadelphia, PA, thousands of scientists and board-certified health professionals will gather to share the latest developments in medical imaging and radiation therapy, examine new clinical and laboratory data, [...]

Medtronic Launches New Midas Rex(R) High-Speed Electric Drill

Posted on June 29th, 2010

Medtronic, Inc. (NYSE: MDT) announced availability of the company’s new Midas Rex® Legend® EHS Stylus Touch™ high-speed electric drill for spinal, cranial and orthopaedic surgical procedures. This is the first electric drill from Medtronic with integrated finger control and is based on the well-established Legend EHS Stylus® motor. With high torque and a compact size, [...]

Supreme Court to Hear Case Regarding Adverse Event Disclosures

Posted on June 22nd, 2010

Authors
Jennifer Y. Dukart
Christin E. Garcia
This week, the United States Supreme Court agreed to review Matrixx Initiatives, Inc. v. Siracusano, a case presenting the question whether securities law plaintiffs must allege statistically significant evidence of harm to survive a motion to dismiss when bringing claims against drug companies for failure to disclose adverse event reports. Shareholders [...]

AtriCure, Inc. Heart Device Gets FDA Approval

Posted on June 15th, 2010

WEST CHESTER, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC – News), a medical device company and a leader in cardiac surgical ablation systems, today announced that it received clearance from the FDA for its AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion system. The AtriClip system is designed to safely and effectively exclude the left atrial appendage. Initial launch [...]

Boston Scientific Announces European Launch And First Implants Of Platinum Chromium TAXUS(R) Element™ Stent System

Posted on June 14th, 2010

Boston Scientific Corporation (NYSE: BSX) announced the market launch and first implants of its TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System in the European Union and other CE Mark countries. The TAXUS Element Stent System is the Company’s third-generation drug-eluting stent (DES) technology and incorporates a platinum chromium alloy with an innovative stent design and an [...]