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Bringing your
medical technology to life
20000+ hours of project support
20,000+
hours of project support

50+

projects

30+

user studies

15+

design solutions

100%

customer return rate

What we do

Human Factors

World-class, compliant strategic human factors consulting for your product's entire lifecycle, from initial user needs analysis through post-market surveillance operations.

Human Factors

User Studies

User Studies

Collect all required data for use-related safety, usability, and user acceptance with our human factors formative and validation studies.

Use-Related Risk Management

Use-Related Risk Management

Identifying and managing use-related hazards to the collection of risk-related information in post-production phases.

User Interface Design

User Interface Design

Systematically optimize safety, usability, and user acceptance, including user instructions, packaging and label concepts, training materials, and hardware and software design solutions.

Software Validation

End-to-end support, from user requirements specification to software maintenance and changes.

Software Validation

Training Courses

Training Courses

Tailored training courses to grow your in-house expertise, delivered by industry-leading professionals with real-world MedTech and Pharma experience.

Schedule an introduction

Schedule an introduction call with a technical expert

Our advantages

Customized support

Customized support

Augment your team's knowledge and expertise efficiently and effectively with complete, tailored product lifecycle support.

Technical, clinical, regulatory expertise

Technical, clinical, and regulatory expertise

​Benefit from 20,000+ hours of applied technical, clinical, and regulatory experience acquired with leading MedTech and Pharma companies.

 Traceability

 Traceability

From requirements specification through design validation, our processes guarantee full traceability between risk items and their respective measures to ensure safety, regulatory compliance, and user acceptance.

Specialized processes

Specialized processes

We take quality seriously. Our specialized processes ensure that all activities and deliverables meet the highest quality assurance standards and can reliably support audits and inspections.

Our clients

From start-ups to Fortune 500 companies, we work with leading MedTech and Pharma companies all around the globe to design and develop cutting-edge medical devices, combination products, and other health-related solutions.

Our clients

What clients are saying

Yu-Ting, Senior Usability Engineer

Medical Device and Combination Product Development

"We realized it was time to consult with a human factors expert when we decided to optimize our procedures for supporting a more efficient and compliant design and development process for our growing and global pipeline of medical products. We chose Ergonomics Factory because of their technical and regulatory expertise and their experience in working with a broad range of different product types and organizations. It’s been over a year since they completed the optimization process, and our team is very happy with the new procedure and how well it integrates our human factors engineering activities and deliverables into our design control process. Most importantly, we can be confident that our human factors engineering process is fit for supporting the design and development of our upcoming product range, and that it is in compliance with the latest regulatory requirements."
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