Certified Accuracy and Reliability

Millar’s compliance with national and international standards and regulations is reflected in our certifications from accredited registrars and notified bodies, as well as licensed devices throughout several countries around the world.

A Millar employee works on life-saving medical devices in Millar’s ISO Class 7 clean room.

Certifications

Quality Management System ISO 13485:2016 badge

Quality Management System ISO 13485:2016

Quality system certification for the design, development, manufacture and distribution of catheters with tip-mounted pressure and pressure-volume transducers and associated accessories for cardiovascular, digestive, orthopedic and respiratory applications.

EC Certificate: Full Quality Assurance System badge

EC Certificate: Full Quality Assurance System

Certificate in respect of the design and manufacturing of sterile catheter-mounted pressure transducers and associated control units.

EC Certificate: Full Quality Assurance System badge

EC Design-Examination Certificate

CE Certification for Mikro-Cath® Design Examination

Australian Certificate of Therapeutic Goods badge

Australian Certificate of Therapeutic Goods

Australian Certificate of Therapeutic Goods

UKCA Certification for Mikro-Catch Design badge.

UKCA Certification for Mikro-Cath Design Examination

UKCA Certification for Mikro-Cath Design Examination

ISO 13485:2016 badge

ISO 13485:2016

Certificate for the development, manufacture and distribution of sensors, subassemblies and meters for the determination of physical and chemical measured values in active (medical) devices.

Connect with Our OEM Solutions Team

Ready to bring your vision to life? We’re here to help. With years of experience in sensor integration, we work with you to turn your ideas into innovative products, speeding up device development and reducing costs.

Members of Millar’s OEM Solutions team meet at Millar headquarters.