Our Services

Human Factors Process Implementation Planning

To implement human factors processes, we at Empathy Medical apply key steps to ensure that the design and development of medical devices are optimized for the user.
Key services that we provide during this stage:

  • Assessment of Current State

  • Stakeholder Identification

  • Establishment of Objectives

  • Development of Human Factors Guidelines

  • Integration into Design Process

  • Risk Management

  • Verification and Validation

  • Documentation and Compliance 

  • Post Market Data and Continuous Improvement 

Exploratory Research

We select the best suited exploratory method and gather data to support your team in the exploratory phase of device design development.

Key services Empathy Medical offers to ease the first steps of device design development:

  • Surveys and Questionnaires
  • Focus Groups
  • In-depth-interviews
  • Ethnographic Research
  • Competitive Analysis
  • Expert Panels

Early Device Design Development

Early device design activities minimize the design challenges that can occur during the Design Validation stage. Empathy Medical offers a variety of approaches to soar through the Validation stage.

Key services that we provide during this stage:

  • Prototype Testing
  • Concept Testing
  • Co-creation Workshops
  • Contextual Inquiry
  • Cognitive Walkthroughs
  • Empathy Mapping

  • Remote User Testing

  • Virtual Reality (VR) Simulations

  • Heuristic Evaluation

  • Verification (Formative) Evaluation

Device Design Validation Testing

Medical Device development file needs data to prove that potential users will be able to handle your product safely and effectively. Empathy Medical offers exactly that. 

Key services related to Device Design Validation activities: 

  • Usability Validation (Summative) Testing
  • Validation of Instructions for Use
  • Validation of Training Materials

Instruction Material Development

Instructional material is essential for medical devices implementation.

Key instructional material development: services that Empathy Medical offers:

  • Instruction for Use (IFU) Development
  • Quick Guide Development 
  • Packaging Development

Regulatory Compliance Strategies

Empathy Medical adheres to the following regulatory pathways:

  • Food and Drug Administration (FDA) in the United States of America (USA).
  • Medical Device Regulations (MDR) in the European Union (EU).
  • Medical and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK).
 Main standards and guidances that we follow:
  • FDA Applying Human Factors and Usability Engineering to Medical Devices.
  • MHRA Guidance on Applying Human Factors Engineering to Medical Devices.
  • ISO-13485- Medical Devices Quality Management System.
  • ISO-14971- Application of Risk Management to Medical Devices.
  • IEC-62366-1 & 2- Application of Usability Engineering to Medical Devices.
  • IEC-62304- Medical Device Software.