Navigation Links
GPMG Product Helps Medical Device Specification Developers be FDA and ISO 13485 Compliant
Date:2/28/2013

GARDNER, Mass., Feb. 28, 2013 /PRNewswire/ -- Global Pacific Manufacturing Group LLC's (www.gpacmfg.com), quality system product helps specification developers be ISO 13485 Certified and FDA QSR compliant in 3 months or less. The GPMG base quality system product includes 28 standard operating procedures governing product development and post commercialization activity.

GPMG's Vice President and General Manager, Aaron Lyon notes that "This new product will allow medical device developers seeking ISO 13485 certification to meet 85-90 percent of their goal on day one. The remaining effort is on aligning the system with any unique activities and the company's organizational structure. The product allows companies to focus on product development instead of quality system development."

The procedures guide development teams to identify user needs, define product performance requirements, and convert user needs into technical specifications. Design reviews, conducted at each stage of development, use detailed forms that offer guidance on topics reviewed and serve to document each review.  

The system includes application of risk management per ISO 14971 and design analysis tools. The system also addresses the content and construction of Design History Files and Device Master Records and the management and control of documentation. Controls over materials, supplier management, and corrective and preventive actions are also included. Further, GPMG has developed numerous individual procedures that can easily be added to the base system to match each company's unique business activities.

The system installation follows GPMG's long-established approach of Adopt, Align, Train, and Certify:

  • Adopt the system to match an organizations products, markets, and policies.  
  • Align each procedure with the manufacturer's organization structure, activity, and preferences 
  • Train core staff in a logical sequence
  • Provide ongoing support until certification.

GPMG is confident medical device specification developers seeking ISO 13485 certification and FDA QSR compliance will take full advantage of this cost-effective solution.

About GPMG:

Global Pacific Manufacturing Group LLC is a privately held medical device consulting firm that assists medical device manufacturers 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)

PRLog ID: www.prlog.org/12087572


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

Related medicine technology :

1. Report Presents a Framework for Successful New Oncology Product Launches in the Pharmaceutical Sector
2. Sensitech Inc. Products Receive Regulatory Compliance Approval from IATA
3. Haemonetics Signs Definitive Agreement to Acquire Pall Corporations Blood Collection, Filtration and Processing Product Lines For $551 Million
4. QIAGEN and Cardinal Health Collaborate to Offer Molecular Diagnostic Products to Smaller and Mid-sized U.S. Hospitals
5. Diabecline Antibiotic Receives Edison Award for Best New Pharmaceutical Product
6. China Biologic Products to Host Earnings Conference Call on May 9, 2012 at 8:00 a.m. EDT (NY)
7. National Stakeholders Meet To Consider Improvements In Antimicrobial Use In Food Animal Production
8. New Reproductive Support Dietary Supplement, Pregnitude™, Now Available For Women Having Difficulty Conceiving
9. China Biologic Products Reports Higher Results for the First Quarter 2012
10. Clinical Interest in BioElectronics Products Expands to the Wound Care Market
11. Allied Healthcare Products Reports Loss on Sales Decline
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 Roche ... received 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) ... severe sepsis or septic shock. With this clearance, Roche ... provide a fully integrated solution for sepsis risk assessment ... associated with bacterial infection and PCT levels in blood ...
(Date:6/23/2016)... VIEW, Calif. , June 23, 2016 ... a.m. CST on Thursday, July 7, 2016 , , , ... kayla.belcher@frost.com ) , , , , EXPERT PANELISTS:  , ... Nitin Naik; Senior Industry Analyst, Christi Bird; Senior Industry Analyst, Divyaa ... The global pharmaceutical industry is witnessing an ...
(Date:6/23/2016)... 23, 2016 The vast majority of dialysis ... facility.  Treatments are usually 3 times a week, with ... including travel time, equipment preparation and wait time.  This ... grueling for patients who are elderly and frail.  Many ... and rehabilitation centers for some duration of time. ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer is helping ... fitness app. The fitness app plans to fix the two major problems leading the fitness ... size fits all type program , They don’t eliminate all the reasons people ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... "With 30 ... their specific project," said Christina Austin - CEO of Pixel Film Studios. , ... and all within Final Cut Pro X . Simply select a ProHand generator ...
(Date:6/25/2016)... ... ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter of indulgence ... high can result in disappointment, perhaps even self-loathing. However, those who set the bar ... from PsychTests.com reveals that behind the tendency to set low expectations is ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... ... Conference and Scientific Sessions in Dallas that it will receive two significant new ... the grants came as PHA marked its 25th anniversary by recognizing patients, medical ...
(Date:6/24/2016)... ... , ... People across the U.S. are sharpening their pencils and honing their ... in which patients and their families pay tribute to a genetic counselor by nominating ... of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In April, ...
Breaking Medicine News(10 mins):