ISO 13485 Accreditation: Elevating Quality and Confidence in Medical Device Manufacturing


In the ever-evolving landscape of medical device manufacturing, quality and safety are paramount. Our team at Pilotfish are thrilled to announce our ISO 13485 accreditation, certified by Bureau Veritas, marking a significant moment in our commitment to excellence in medical device development.

But what does this accreditation mean? Our ISO 13485 accreditation isn’t just a badge; it’s a testament to our commitment to quality and safety.


We’ve taken our 20+ years of product development experience and integrated it into a comprehensive quality management system that covers the entire product lifecycle.


This process combines our design, engineering, industrialisation, and manufacturing expertise with ISO 14971-based risk management and IEC 62366-based human factors engineering services.


What does all this technical jargon mean in practice? It means we can take your vision and create a safe and user-friendly medical device.


Our process reduces development risks, ensuring that your device meets the highest safety standards and regulatory requirements. It’s about more than just compliance.


With decades of experience bridging the gap between people and technology, we bring our unique perspective to create genuinely user-centred designs and innovations that resonate with healthcare professionals and patients alike.

What’s up?

“Are you looking for a partner who can guide you to create unique user experiences and help you to achieve your digital challenges? Let’s get in touch and tell us what you have in mind.”

Marc Nagel, Managing Director