Quality Standards

At ITL BioMedical, quality is at the core of everything we do. For more than 25 years, we have been a trusted leader in global healthcare, backed by a dedicated team of over 300 professionals worldwide. We are committed to ensuring the highest level of medical device performance by maintaining rigorous quality management standards.  

We have established, documented, and implemented an effective quality management system that is continually reviewed and audited for effectiveness. This system complies with ISO 13485:2016 (Medical Device Quality Management Systems), EC Directive 93/42/EEC (CE Mark), and FDA CFR Part 820 (Quality System Regulation).

Quality Manual

Our quality management system governs the development and manufacturing of medical procedure kits and single-use sterile and non-sterile medical devices. This framework ensures that every product is designed, produced, and delivered with reliability, safety, and consistency in mind.

Classifications and Registrations

Our medical devices meet stringent global regulatory requirements.

CE Marked: In accordance with the Medical Device Directive (EC Directive 93/42/EEC)
FDA Registered: Including 510(k) registrations where applicable
ARTG Listings: As required in Australia
Other Approvals: Additional registrations are maintained in line with respective country regulations

This broad compliance framework enables us to serve healthcare providers and patients across multiple regions with confidence.

Controls

To meet the highest standards, our products are manufactured in Class 100,000 or ISO Class 8 rated cleanrooms. TUV SÜD Product Service GmbH serves as ITL’s Notified Body for ISO 13485 QMS and CE-marked devices.

Our manufacturing facility is also registered with the FDA and is subject to regular FDA audits to ensure full compliance with FDA 21 CFR Part 820. These controls safeguard quality at every stage of production.

Quality Policy

We are dedicated to delivering medical products that meet the needs of our customers and the expectations of regulators. Our quality policy reflects a commitment to:

Meeting all customer and regulatory requirements
Driving continuous improvement in products, processes, and systems
Ensuring safe, effective, and reliable devices for patient care

This policy reflects not only compliance but also our culture of innovation, with more than 50 patents and 37 trademarks demonstrating our ongoing drive to improve safety and efficiency in healthcare and veterinary environments.

Environmental Policy

ITL BioMedical also recognizes the importance of environmental stewardship. We are committed to protecting the environment, voluntarily seeking to prevent pollution, and complying with relevant regulatory and legal requirements throughout the product realization process.

Download our full Environmental Policy here.

Learn more about our broader Sustainability Commitment here.