In Context
The Challenge
Airway Medical Innovations required support to finalise and document the development of their first device, particularly around risk management, device verification and validation, and demonstrating compliance with regulatory requirements.
Wanted to derisk its product, define thorough verification and validation plans and evolve and detail its existing technical file submission documentation.
Perdigo's Approach
Perdigó is always flexible when entering an existing development, adapting to the project status and focussing on its client’s needs.
The ever-evolving design of the Airway Shield was finalised and documented in specifications, drawings and a feature function map.
Has been key to the success of this project. provided an integral solution, working closely with clinical experts at Airway Innovations to complement their expertise in medical device development.
Previously undetected product risks were identified and effectively mitigated, resulting in a more robust device.
A focused documentation plan was also designed to streamline the process and support regulatory compliance.
Delivered Value
The Technical File delivered by Perdigó have enabled Airway Medical Innovations to certify its own Quality Management System, and successfully submit the Airway Shield device for clinical trials and EU market approval.
Furthermore, the Airway Shield has also been designated by the United States’ Food and Drug Administration (FDA) as Safer Technology (SteP).
Has Perdigó has supported a safer, more reliable Airway Shield by identifying and mitigating risks, and streamlining the regulatory process through a focused documentation plan. As a result, the product is now on the market, offering healthcare professionals a cost-effective solution for safer endotracheal intubation.
