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:3/27/2017)... SAN DIEGO and VANCOUVER, British Columbia, March 27, ... SPHS ) (the "Company" or "Sophiris"), a clinical ... treatment of patients with urological diseases, today reported ... and key corporate highlights. Key ... in Clinical Development for Localized Prostate Cancer. During ...
(Date:3/27/2017)... , March 27, 2017 /PRNewswire/ - INVICTUS MD ... IVITF; FRA: 8IS) Invictus MD is pleased to announce ... shares for trading on the TSX Venture Exchange.  ... TSXV follows a year of significant achievements for Invictus-MD. ... successful test crops at AB Laboratories Inc. ("AB Labs"), ...
(Date:3/27/2017)... , March 27, 2017 The ... reach USD 16.0 billion by 2025, according to a ... prevalence of chronic diseases is anticipated to be responsible ... which thereby widens the scope for growth during the ... bariatric population, which is highly susceptible to chronic diseases, ...
Breaking Medicine Technology:
(Date:3/28/2017)... Appleton, WI (PRWEB) , ... March 28, 2017 ... ... how self-funded health plans work, the Self-Funding Success website has recently developed and ... about Self-Funded Health Plans ” was created based on common inquiries the site’s ...
(Date:3/28/2017)... CA (PRWEB) , ... March 28, 2017 , ... ... Carson Liu of SkyLex Advanced Surgical, Inc. is thrilled to offer the recently ... balloon procedure, and this procedure adds to SkyLex Advanced Surgical’s already comprehensive ...
(Date:3/28/2017)... ... March 28, 2017 , ... Oily skin is a common and unwelcomed occurrence in people of ... a lot to offer to the discussion of dealing with excess skin oil. “Oily skin ... many home remedies that can help remove the oily shine while keeping the skin fresh ...
(Date:3/27/2017)... ... March 27, 2017 , ... New patients who have sleep apnea ... with or without a referral. Sleep apnea is often left untreated because patients are ... headaches and chronic snoring. , Dr. Braasch seeks to raise awareness of sleep ...
(Date:3/27/2017)... Philadelphia PA and London UK (PRWEB) , ... ... ... have the speed, agility and ability to gain site attention and engagement over ... DrugDev educational webinar will discuss how partnering with the ...
Breaking Medicine News(10 mins):