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:11/26/2015)... DUBLIN , November 26, 2015 /PRNewswire/ ... the addition of the "Radioimmunoassay Market ... User (Hospital, Pharmaceutical Industry, Academics, Clinical Diagnostic ... - Global Forecast to 2020" report ... ) has announced the addition of the ...
(Date:11/25/2015)... DUBLIN , Nov. 25, 2015 /PRNewswire/ ... announced the addition of the "Global ... to their offering. --> ... "Global Brain Monitoring Devices Market 2015-2019" ... Research and Markets ( ) ...
(Date:11/25/2015)... OAKS, Calif. , Nov. 25, 2015  Amgen ... a Biologics License Application (BLA) with the ... (FDA) for ABP 501, a biosimilar candidate to Humira ... first adalimumab biosimilar application submitted to the FDA and ... pathway. Sean E. Harper , M.D., executive ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... ... the No.1 Herpes-only dating community in the world, revealed that over 50% of its members ... billion people under the age of 50 – or 67% of the population - are ... of HSV-1 infection . , "The data shocks us highly!" said Michelle Li, Co-Founder ...
(Date:11/27/2015)... ... 27, 2015 , ... Keeping in mind challenges faced by ... wellness consultation, has collaborated with a leading web-based marketplace for extra-curricular activities for ... parents and bring advice from parenting experts within their reach. As a part ...
(Date:11/27/2015)... ... November 27, 2015 , ... Indosoft ... announces the incorporation of Asterisk 11 LTS (Long Term Support) into its Q-Suite ... LTS brings Q-Suite 5.10 up-to-date with a version of Asterisk that will receive ...
(Date:11/26/2015)... ... November 26, 2015 , ... The ... bioavailability and the need to integrate dose form selection in early phase drug ... the membership organization supporting and bringing together the UK’s emerging life sciences companies, ...
(Date:11/26/2015)... ... November 26, 2015 , ... Health-E-minds ... collaborated with Women’s Web – an online resource for Indian women looking ... and emotional well-being relationship, life balance, stress, professional development, and lifestyle. Health-E-minds ...
Breaking Medicine News(10 mins):