Case Study: Technology Partner for Regulatory Tool Design

>> Turnkey development of web tool set to help start-up medical device companies in their regulatory submissions

Agiliad’s Role

  • End to end development of the online tool chain
  • Active participation in defining the requirements of the individual tools
  • Development of Ruby in Rail based online web tools
  • Database design to support multiple companies, regulatory checklist and documents
  • Maintenance and deployment of the tool on the cloud infrastructure

Program highlights


The company is started by a highly accomplished regulatory consultant, who helped medical OEMs across globe to get regulatory approval in USA and other geographies. The solution contains multiple tool set to plan, track and verify the compliance and also perform risk assessment.

Agiliad Solution

The Agiliad’s technology team with regulatory process expert were involved on this product right from the concept phase including performing a proof of value and technology. The solution involves designing the cloud based web tool, selecting the technology and third party components, developing and test automation of the tool.

Agiliad value proposition and customer benefits

  • Assist in defining process checklist and workflows based on our regulatory process experience
  • Agile approach to develop the tools to reducing time to market
  • End to end responsibility from development to infrastructure selection (cloud environment, payment gateway etc.) and deployment