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More than Human Factors Engineering.
 
 

ISO 13485 certified expert services for medical technology innovators.

20000+ hours of project support
23,000+
hours of project support

60+

projects

35+

user studies

20+

design solutions

100%

customer return rate

What we do

Compliant expert human factors engineering services for your product's entire lifecycle, from initial user needs analysis through post-market surveillance operations.

Human Factors Engineering

User Studies

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

Use-Related Risk Management

Identifying and managing use-related hazards from pre-design control through post-production stages.

User Interface Design

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

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

Software Validation

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

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

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

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

We take quality seriously. Our specialized processes ensure that all activities and deliverables are in accordance with ISO 13485 and meet the highest quality assurance standards to 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

Francesca, Senior Marketing Manager

Multinational Medical Device Manufacturer

"Working with Ergonomics Factory has been an exceptional experience! Their expertise in developing medical device instructions for use, quick reference guides, package labelling, illustrations, and translation services exceeded our expectations. The team's attention to detail, efficiency, and dedication to delivering a high-quality product has been truly commendable. We greatly appreciate their commitment to understanding our unique requirements and providing tailored solutions that perfectly align with our needs. It's evident that Ergonomics Factory values customer satisfaction as they went above and beyond to ensure a smooth and successful collaboration. We look forward to future projects with this outstanding team. Thank you for your professionalism and excellence!"
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