News
Our new Czech factory has been granted ISO 13485 certification
What is ISO 13485?
ISO 13485 is the internationally recognised standard for quality management systems in the design and manufacture of medical devices. It sets the framework for making sure medical devices meet customer and regulatory requirements for safety and performance.
Why it matters to our clients
ISO 13485 is the internationally recognised standard for quality management systems in the design and manufacture of medical devices. It sets the framework for making sure medical devices meet customer and regulatory requirements for safety and performance.
- Risk management: A systematic approach to identifying and reducing risks across the product lifecycle, protecting the people who use our products.
- Regulatory compliance: A framework that helps us meet the requirements for medical device manufacturing.
- Efficiency: Streamlined processes that reduce waste and improve productivity.
- Market access: Standardised compliance that supports entry into markets around the world.
- Trust: Independent evidence of our commitment to safety and quality for regulators, customers and end users.
Certified from day one
Achieving ISO 13485 certification so soon after opening reflects how we’ve designed our highly automated new Czech facility. Exceptional quality management has been built into how the factory operates from the start – it’s not an afterthought we’ve bolted on afterwards.
Talk to us
To discuss EU-made incontinence or period underwear for your range, contact us at [email protected]
