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:6/26/2016)... 2016 Jazz Pharmaceuticals plc (Nasdaq: ... Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ("HSR"), ... Inc. ("Celator"; Nasdaq: CPXX ) expired effective ... As previously announced on May 31, 2016, ... agreement under which Jazz Pharmaceuticals has commenced a tender ...
(Date:6/24/2016)... N.J. , June 24, 2016  Collagen ... the design, development and manufacturing of collagen and ... regeneration announced today that Bill Messer ... and Marketing to further leverage the growing portfolio ... medical devices. Bill joins the Collagen ...
(Date:6/24/2016)... Research and Markets has ... 2015-2025: Applications, Technologies, Forecasts" report to their ... Electronics, Smart Skin, Structural Health Monitoring, Composite Smart ... electronics involves electronic and/or electrical components and circuits ... structures such as vehicle bodies or conformally placed ...
Breaking Medicine Technology:
(Date:6/25/2016)... Miami, FL (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton ... Plant City Observer , brings up a new, often overlooked aspect of head lice: ... The closing for fumigation is not a common occurrence, but a necessary one in the ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... On Friday, ... presented a Bronze Wellness at Work award to iHire in recognition of their exemplary ... part of the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was ... his family verbally and physically. , “When something upset him, he couldn’t control his emotions,” ... He would throw rocks at my other children and say he was going to kill ...
(Date:6/24/2016)... ... 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ... raise to $12 an hour by 2020 and then adjusting it yearly to increase at ... the minimum wage, assure the wage floor does not erode again, and make future increases ...
(Date:6/24/2016)... ... 24, 2016 , ... Strategic Capital Partners, LLC (SCP) in ... investment capital for emerging technology companies. SCP has delivered investment events and ... more than a million dollars of capital investment for five companies. ...
Breaking Medicine News(10 mins):