ITL maintains a high level of performance by committing to quality and environmental management standards. We have established, documented, and implemented a quality and environmental management system that is continuously reviewed and audited for effectiveness in accordance with ISO 9001 (Design, Manufacture & Supply), ISO 13485 (Medical Device Quality Management Systems), EC Directive 93/42/EEC (CE Mark), FDA WQSR 21 CFR part 820 (Quality System Regulation), and ISO 14001 (Environmental), and ISO 11135 (Sterilisation).
The quality manual covers our development and manufacturing of medical procedure kits, single-use sterile and non-sterile medical devices, and reusable medical devices.
Our products are CE marked, according to the Medical Device Directive (EC Directive 93/42/EEC) and or registered with the FDA (510k) and or on the ARTG and or respective country’s medical device regulation where applicable. Current highest product classification developed and manufactured by ITL are as per MDD class 3 and as per FDA QSR class 3, respectively.
Products are manufactured in clean rooms Class 100,000 or ISO Class 8 respectively. TUV SUD Product Service GmbH and the TGA audit our quality management system annually in addition with regular inspection by the US FDA. SGS conducts an annual audit on our environmental management system in Malaysia.
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.