Navigation Links
GPMG Unveils a Quality System Product Designed for Initial Importers of Medical Devices
Date:2/27/2013

GARDNER, Mass., Feb. 27, 2013 /PRNewswire/ -- Global Pacific Manufacturing Group LLC (www.gpacmfg.com), has developed a practical and cost-effective quality system to help the thousands of current and future Initial Importers be FDA compliant.  

A typical Initial Importer buys products from foreign manufacturers and introduces them into the United States market; therefore, they are subject to FDA controls. A large percentage of these companies are small entities with limited resources. As a result, many are operating in varying states of noncompliance.

Recognizing Initial Importers need help with meeting the FDA requirements, GPMG developed a series of procedures aligned with the typical Initial Importer resource structure. The procedures were then refined to reduce the effort and time required to execute the process steps contained within each procedure. The resulting product was a realistic system that meets the FDA requirements upon installation and helps ensure continued use.

Current FDA efforts to reduce the amount of adulterated product entering the United States is leading to an increased emphasis on the supply chain. Initial Importers will undoubtedly face increased scrutiny over their business activities in the coming years. Providing a solution to these compliance challenges is a benefit to everyone involved, including the public.

Initial importers play an important role in the medical device supply chain. GPMG is confident that current and future Initial Importers will take full advantage of this practical and cost-effective compliance solution.

The Initial Importer operating system includes detailed procedures for:

- Complaint Handling and Trending

- Medical Device Reporting

- Remedial Action / Recall

- Product Hold

- Supplier Management

- Document and Change Control

- Management Review

- Corrective and Preventative Action

- Internal Audits

- Training and Job Descriptions

About GPMG:

Global Pacific Manufacturing Group LLC is a privately held medical device consulting firm that assists medical device manufacturers of all sizes with product development and regulatory compliance globally.

To learn more about Global Pacific Manufacturing Group LLC products and services visit them at:  www.gpacmfg.com

Media Contact Information:

Aaron Lyon
Global Pacific Manufacturing Group
202-380-9380 (office)

Photo(s):
http://www.prlog.org/12087042


'/>"/>
SOURCE Global Pacific Manufacturing Group LLC
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Laboratory Supply Distributors Corp. Unveils New Product Catalog
2. Smt. Sheila Dikshit Unveils South Asias First PET SUITE at Indraprastha Apollo Hospitals
3. Medbox, Inc. Unveils Customer Financing Program
4. Sony Unveils Work-In-Progress 20.5-inch OLED Display
5. HemoShear Unveils In Vitro Steatosis System at Annual Meeting of the Association for the Study of Liver Diseases
6. Hoggan Scientific Unveils Updated ergoFET Force Gauge for Improved Force Evaluation
7. Sigma-Aldrich Enhances Customer Focus in China - Unveils Dynamic New Website and Expands Product Offering Through Vetec Brand
8. AVT Unveils New Wall Mounted Automated Medicine Information and Dispensing System
9. MGC Diagnostics Corporation Launches New Corporate Website and Unveils New Logo
10. Optimal Radiology Unveils New Brand
11. Infuse Medical unveils EtherDCP for Mobile Application Management (MAM)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2017)... PHILADELPHIA , Oct. 2, 2017 Halo Labs announces ... particle analysis system called the HORIZON at MIBio 2017 in ... analyzes subvisible and visible particulate matter in biopharmaceutical samples with unprecedented ... use of the novel technique Backgrounded Membrane Imaging. ... The HORIZON subvisible particle analysis system ...
(Date:9/27/2017)... Sept. 27, 2017  Commended for their devotion to personalized ... Ranked as number one in the South Florida Business Journal,s ... Inc. 5000 yearly list, the national specialty pharmacy has found ... Bardisa will soon be honored by SFBJ as the ... Set to receive his award in October, Bardisa ...
(Date:9/23/2017)... Janssen Biotech, Inc. (Janssen) announced today that ... U.S. Food and Drug Administration (FDA) for the Biologics ... treatment of moderately to severely active rheumatoid arthritis (RA). ... needed to further evaluate the safety of sirukumab in ... "We are disappointed ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many kids ... sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids excited ... all ages; it is a non-competitive, non-timed event, which is all about having fun ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to the ... save lost souls in the Philippines. “The Journey: From the Mountains to the Mission ... of the Bible. She has taught all ages and currently teaches a class of ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the ... today its plans to open a flagship location in Covington, LA at 401 N. ... To Go store next to Office Depot in the Holiday Square shopping center. Its ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally recognized ... have expanded their existing home health joint venture through an agreement, effective October ... a joint venture home health company with Asante, delivering clinically integrated care, for ...
(Date:10/12/2017)... Washington, D.C. (PRWEB) , ... October 12, 2017 , ... ... of their peers in Washington, D.C., for the 49th Congress of the International ... Ph.D ., Vice President of the Center for Cancer and Blood Disorders ...
Breaking Medicine News(10 mins):