ITL maintains a high level of medical device performance by commitment to established quality management standards. We have established, documented, and implemented an effective quality management system that is continuously reviewed and audited for effectiveness in accordance with ISO 13485 -2016(Medical Device Quality Management Systems), EC Directive 93/42/EEC (CE Mark) and FDA CFR part 820 (Quality System Regulation).
The quality management system covers our development and manufacturing of medical procedure kits, single-use sterile and non-sterile medical devices.
Our medical devices are CE marked, in accordance to the Medical Device Directive (EC Directive 93/42/EEC), registered with the FDA (510k registration), on the ARTG and or respective country’s medical device regulation where applicable.
Products are manufactured in Class 100,000 or ISO Class 8 rated cleanroom respectively. TUV SUD Product Service GmbH is ITL’s Notified Body for ISO 13485 QMS and CE Marked devices. ITL’s manufacturing facility is registered under FDA and is subject to periodic FDA audits for compliance to FDA 21CFR Part 820.
We are committed to delivering quality medical products to our customers. We meet customer and relevant regulatory requirements and advance products and processes through continuous improvements.
We believe in protecting the environment, and we voluntarily seek to prevent pollution. We have implemented an environmental management system that complies with relevant country, regulatory, and legal requirements throughout the product realisation process.