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Documentation and Regulatory

For over 30 years, Omnica has turned concepts into reality when designing medical devices and instruments for our client-manufacturers. Central to our methods is the ability to remain swift and nimble when creating and iterating designs. We have the ability to tailor a program to meet the specific requirements of each client during design and development. This allows us to capture and organize their design data and support their Design Control process, while they build Design History Files (DHF) as defined in their Quality System. In this way, we can generate comprehensive custom project documentation packages.
 

Read our Introduction to Design Control
 

Documentation for manufacturing and FDA compliance is a key service at Omnica.

Below are typical services we perform, coordinate, and/or support during the design and development cycle of a medical device or instrument. Due to the unique challenges of each project, additional regulatory requirements sometimes lead to activities necessitating Omnica's involvement or assistance.

 

  • Feasibility testing while evaluating User Needs
  • Formative Usability Testing & Human Factors evaluation
  • Design Input and refinements to requirements and specifications
  • Design Output / Design for Manufacturing (DFM)
  • Risk Management and Assessment
  • Design Verification and Validation (V&V)
  • EMC/EMI and Safety testing
  • Production documentation
  • Transfer to Manufacturing (in support of GMP)
  • Summative usability testing
  • 510(k) or IRB documentation support

 

Do you need an ISO Registered design and engineering firm to develop your medical device?

 

Although Omnica is not a manufacturer, we have ongoing relationships with various ISO 13485-registered contract manufacturers and understand the qualities that characterize their processes and services. We frequently assist in determining whether potential suppliers and contract manufacturers are qualified to provide components or manufacturing services that meet the unique requirements of our client's medical devices and instruments.

 

While Omnica makes every reasonable effort to ensure the accuracy and professionalism of our services and quality of designs, it should be understood that the client-manufacturer bears the full and final responsibility for determining the suitability, safety, marketability, and overall fitness of the design for any intended purpose. Additionally, the client manufacturer of a medical device is responsible for developing and complying with their Quality System based on the 21 CFR Part 820.