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

FDA Approves New Device To Treat Brain Aneurysms

Posted on April 11th, 2011

The U.S. Food and Drug Administration today approved a new device that provides neurointerventional surgeons with another tool to treat brain aneurysms without performing open surgery. An aneurysm is a weak, enlarged area in an artery (blood vessel). Over time, the force of normal blood pressure can cause it to rupture, which can be life-threatening [...]

St. Jude Medical Receives FDA Approval For New Bi-Directional Ablation Catheters

Posted on April 5th, 2011

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced today that it has received U.S. Food and Drug Administration (FDA) approval of two new irrigated ablation catheters – the Safire BLU(TM) Bi-directional Irrigated Ablation Catheter and the Therapy(TM) Cool Path(TM) bi-directional ablation catheter. These two new catheters have several key design features that [...]

Boston Scientific Receives FDA Approval Of New Clik™ Anchor For Precision Plus™ Spinal Cord Stimulator System

Posted on March 28th, 2011

Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Clik™ Anchor for its Precision Plus™ Spinal Cord Stimulator (SCS) System, the world’s first rechargeable SCS device for chronic pain management. The Clik Anchor features an innovative locking system designed to improve lead anchoring speed and [...]

FDA Approves Device To Maintain Blood Flow During Artery Bypass Brain Surgery

Posted on March 14th, 2011

The U.S. Food and Drug Administration approved a surgical kit that allows neurosurgeons to reroute blood flow around an aneurysm or a tumor in the brains of patients at greater risk of stroke during standard bypass surgery. The ELANA (Excimer Laser Assisted Non-Occlusive Anastamosis) Surgical Kit allows neurosurgeons to create a bypass without shutting off [...]

Covidien Announces FDA 510(k) Clearance Of New LigaSure™ Instrument

Posted on February 21st, 2011

Covidien (NYSE: COV), a leading global provider of healthcare products, announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the LigaSure™ Curved, Small Jaw, Open Sealer/Divider surgical instrument. The device is indicated for use in general surgery and will be available in the United States this quarter. The LigaSure Curved, Small Jaw, [...]