Your company’s success is based on your product. We can support your design control engineering efforts in a variety of ways to allow you focus on your core competencies and get products to market faster.

Benefits of good design control system
A strong design control system is essential in bringing your technology to market in the shortest period of time possible. Not only it will help you meet the regulatory requirements more efficiently, but it will also give you the methodology to develop products that:

  • are “manufacturable”
  • are cost effective
  • will need fewer redesigns
  • will meet customer requirements.

Cross-functional approach
An effective design control system needs to combine a varied set of requirements that overlap a wide range of disciplines.

  • Technology / engineering
  • quality
  • regulatory
  • customer needs

With our biomedical engineering and quality backgrounds, our hands-on experience, we are most able to understand all sides that need to contribute in bringing a product successfully and quickly to market.

Our cross-functional expertise will be used to develop a design control system that will best foster your product development process and provide the most value. It will become the foundation of an efficient and effective new product introduction process.

We will focus on the following aspects of your design control system by making these sub-processes flow seamlessly and easily:

  • Development planning
  • Requirements / design inputs
  • Specifications development
  • Risk analysis
  • Design outputs
  • Design verification
  • Design validation
  • Design reviews
  • Design transfers
  • Assembling the design history file (DHF)

Whether you have an existing design control system that needs to be perfected or you require a complete customized system, Gloster Biomedical International help you build an effective system that will add value to your organization.

We can also tailor simple training sessions and courses to simply teach participants how to perform a specific task or explain the various elements of design control to highlight:

  • their purpose
  • their context
  • how they relate to each other
  • why they are key to the success of the overall project


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

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