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Ergonomics Factory’s ISO 13485 Compliant Quality Management System

Services for design and development of medical devices
ISO 13485 Certificate

As highly specialised service provider for the MedTech and Pharma industries, outstanding service and process quality has been a key-important attribute of Ergonomics Factory’s processes and deliverables from day one on. Through our recent ISO 13485 certification, we demonstrate the compliance of our processes with one of our industries‘ most important quality standards.

To you as Ergonomics Factory customer, the ISO 13485 certification demonstrates the level of reliability, quality, and regulatory compliance you can expect when entrusting us with supporting you in the design and development of your medical devices and drug-device combination products.

For Ergonomics Factory, the ISO 13485 certification has been an important milestone for strengthening our leading position in Switzerland as expert service provider of medical device human factors engineering, software validation, and user interface design, and supports our current growth trajectory on our way to becoming one of the most renown human factors engineering and user interface design partners within Europe’s MedTech and Pharma industries.

Want to find out more about us and our work? Book a free introduction call. We’re always happy to discuss your project with you and eager to find the most efficient and effective way for supporting you and your teams to provide patients, users, and healthcare providers around the globe with innovative, safe, and effective solutions.


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