Navigation Links
GPMG Unveils a Quality System Product Designed for Initial Importers of Medical Devices

GARDNER, Mass., Feb. 27, 2013 /PRNewswire/ -- Global Pacific Manufacturing Group LLC (, 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:

Media Contact Information:

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


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:
(Date:11/24/2015)... N.Y. , Nov. 24, 2015 Avery ... System, is pleased to announce the appointment of ... Dr. ... pediatric cardiology at Children,s Hospital, Uppsala University, Uppsala and ... From 1984-1986, he was a fellow at the Cardiovascular ...
(Date:11/24/2015)... India , November 24, 2015 ... . --> adds Latest Guidebook ... report of 217 pages published in November 2015 ... its online business intelligence library at ... one of the fastest growing global economies with ...
(Date:11/24/2015)... , Nov. 24, 2015  Ascendant Solutions, Inc. (Pink Sheets: ... its Board of Directors has declared a special 1 percent ... dividend is payable December 14, 2015, to shareholders of record ... form of additional shares of common stock. ... Board is a strong endorsement of our confidence in Ascendant,s ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... Bunion Bootie , the ... celebration of the early holiday shopping season. Starting Wednesday November 25th, Bunion Booties ... Black Friday promotional pricing is in addition to any automatic discounts applied when ...
(Date:11/24/2015)... ... , ... Dr. Todd S. Afferica, a noted general dentist in Norcross, ... Dr. Afferica now uses the BIOLASE WaterLase iPlus 2.0™ in many of his dental ... other traditional cutting tools, such as the scalpel and high-speed drill, which can both ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... Charitable giving ... charitable donations are made in the last five weeks of the year totalling over ... created in 2012 to connect the nation’s charities with those individuals who want to ...
(Date:11/24/2015)... ... November 25, 2015 , ... Catalent Pharma Solutions, the ... consumer health and global clinical supply services, today announced that Dr. Christine Milligan, ... East Asia Conference, to be held at the InterContinental Seoul COEX Hotel, Seoul, ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... Preparing for ... p.m. – 3:00 p.m. EST, , FDA has long asserted that ... regulations apply to performing the tests and do not meet the device regulations. , ...
Breaking Medicine News(10 mins):