An effective quality management (QMS) system is critical.

Whether your company manufactures, designs, packages, sterilizes or only a distributes medical devices, a robust quality system enables your organization to identify, measure, control and improve the various core business processes that will ultimately lead to improved business performance. It can be thought as being the “core infrastructure” of your organization. 

An ineffective quality system or lack of compliance to a quality system might result in:

  • Delays in receiving approval (from FDA, Notified Body, Competent Authority, MHW, TGA, CMDCAS),
  • Delays in introducing new products to markets
  • Costly quality problems
  • Inability to identify root causes to manufacturing problems
  • Expensive product recall
Gloster Biomedical International has the expertise to develop or modify your quality system to accommodate the domestic and international regulatory requirements that you are targeting. We will take a comprehensive approach.

We will deliver a turnkey system or assist you in upgrading your quality management system to flawlessly achieve FDA QSRs, ISO and MDD regulations. Our goal is to deliver procedures that allow you to be compliant, while remaining user friendly and require minimum maintenance.

Quality Management Representative

You may not have sufficient internal resources to develop and support your own quality system. In addition to creating and enhancing your QMS, let us assist you when interacting with FDA or other regulatory agencies. We will act on your behalf and be your management representative.

» This will allow you to utilize our long experience of working with FDA and other agencies, thus initiating from the very beginning a positive and fruitful relationship with your regulatory body.

Specific Quality Systems
You may have an existing quality system that you are satisfied with. We can assist you in performing a gap assessment to evaluate the compliance risks of your current system and then only focus on the key areas that need improvements. In particular, we can help you with:

Contact us and let us know what you need.

We will give you the edge in the highly competitive and regulated environment to be successful.

We can help you adapt to market demands swiftly.


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Gloster Biomedical International • 577 N. Hope Ave, Suite 101 • Santa Barbara, CA 93110 • USA • Tel: +1-805-679-1258

Copyright © 2008-2009 Catherine Gloster - Gloster Biomedical International - All rights reserved.