Garrett
process

We believe that risk analysis and risk management is crucial to both medical and consumer devices. Our ability to identify project, product and consumer risks helps alleviate costly oversights early in the design process. We practice early identification of hazard controls using our risk analysis system in order to build robustness and traceability in your project.


QUALITY

Our quality process ensures that your device will perform as required, works in a safe manner and meets your development schedule. Our process is ISO 13485 certified and is rigorous but not burdensome. It can be used stand-alone or in conjunction with a client’s system. If needed, we can also seamlessly utilize your system alone.

  • Quality System follows strict guidelines which eases the process of 510K & PMA submissions
  • Meets FDA requirements established in 21 CFR 820.3 and 21 CFR 820.30
  • Designed for Class III medical device development
  • ISO 13485 certified
  • ISO 9001 compliant

RISK ANALYSIS

We believe that risk analysis and risk management is crucial to both medical and consumer devices. Our ability to identify project, product and consumer risks helps alleviate costly oversights early in the design process. We practice early identification of hazard controls using our risk analysis system in order to build robustness and traceability in your project. Our risk analysis process is compatible with EN 60601 standards.


DEVELOPMENT MODEL

Our development model starts with your requirements and follows specific tasks designed to minimize risk and maximize output. With this model we can work independently or in tandem with client teams.


SPIRAL DESIGN PROCESS

Our spiral design process utilizes a spiral model providing multiple prototype releases throughout the development cycle. This allows for early verification of product performance and allows identification of specification changes, user interface performance and hazard controls early in the process.


VERIFICATION AND VALIDATION

Through our verification and validation process, we will ensure that the performance of the product will meet your specifications and the requirements of both regulating agencies and your customers.

  • Product Specification Development
  • Verification and Validation Procedure Development
  • Risk Analysis
  • Fault Tree / FMEAC Analysis
  • Software and Hardware
  • Process Validation
  • Product Design History File, Verification and Agency
    Testing Remediation
Bringing Your Ideas To The Market
 
 
© 2012
SITE DESIGN BY ONE ZERO CHARLIE