Gilero main office page header image 2

Athlone, Ireland

Athlone, Ireland (Design Center)

Gilero’s design center in Athlone, Ireland serves as our fourth Design Center, adding a European presence to Gilero’s existing locations in the United States. Athlone gives us a great gateway to the European market, and it is a great community that has proven to be successful within the MedTech industry. Located in the heart of Ireland, the new Design Center’s location will allow Gilero to conveniently support clients from Galway to Dublin and everywhere in between. The Ireland Design Center will provide the same high level of engineering expertise that Gilero is known for, with a strong focus on device design and product development.

Specialities & services through this office:

  • Understand Requirements
  • Research Existing Technologies
  • Understand Patent Landscapes

  • Brainstorming
  • Concept Sketches
  • Early CAD
  • Technical Reviews

  • Early-Stage Development (Phase 0)
  • Design and Development Planning (Phase 1)
  • Design Inputs (Phase 2)
  • Design Outputs (Phase 3)
  • Design Verification & Validation (Phase 4)
  • Transfer Design to Production (Phase 5)

  • Formative and summative human factors studies required for regulatory submission
  • HFE planning
  • Contextual inquiry
  • Focus groups
  • Ethnographic research
  • Participatory design sessions
  • Task analysis
  • Use-related risk analysis (URRA)
  • Use failure modes and effects analysis (uFMEA)
  • Label comprehension studies
  • Comparative analysis
  • Threshold analysis
  • Instructions for use (IFU)
  • HFE/UE summary reports

  • Proof-of-concept
  • Functional prototypes
  • 3D printing
  • Silicone and injection mold tooling
  • PCB (printed circuit boards)
  • Breadboarding
  • IT integration simulation

  • Proof of Concept Testing
  • Design Verification Testing

  • Regulatory Assessments
  • Medical Device Classifications
  • US FDA Strategy
  • 510(k) submissions
  • PMA (Pre-market approval) submissions

BSI Icon