Our Services

Human Factors Process Implementation Planning

Implementing human factors processes involves several key steps to ensure that the design and development of systems or products are optimized for human use and interaction.
Key elements that are important 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

There are number of ways to prepare your design for the next development stage. Each exploratory method applied could formulate a more accurate approach that your team is planning to take when proceeding into the next device design development stage.

Key approaches Empathy Medical offers to its clients 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 Activities

Early device design activities could minimize the design challenges that might occur later on in the Design Validation stage. Empathy Medical offers a variety of approaches that helps clients to soar through the Validation stage.

Key services:

  • 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 proof (data) that potential users will be able to use 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

An essential element that adds on to the completeness of the medical device functionality are the instructional material. As it is very difficult to attract users to use these assisting tools, Empathy Medical is ready to help manufacturers create instructional materials that are impossible to avoid.

Key services related to instructional material development:

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

Regulatory Compliance Strategies

Three main areas Empathy Medical imbedded into its processes and procedures when it comes to regulations:

  • 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).
A few main standards and guidances that Empathy Medical follows:
  • 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 and 2 – Application of Usability Engineering to Medical Devices.
  • IEC – 62304 – Medical Device Software.