In support of continuously broadening our product offerings, we maintain high quality standards for our operations, products and services. This is key to our strategies concerning sustainable development and sustainable compliance. Our quality policy therefore emphasizes that we continuously assure that the quality is maintained  through development, manufacture and distribution of our products to satisfy customer, patients and stakeholders.

Laws and regulations for medical technology
The implementation of our quality policy is supported by a quality management system, compliant with laws and regulations in the field of Medical Industry, including, but not limited to:

• EU MDD 93/42/ECC
• US FDA 21CFR parts 803, 806, 807, 820
• Japanese MHLW Ministerial Ordinance
• Canadian SOR 98/282
• Australian Therapeutic Goods (Medical Devices) Regulation 2002
• ISO 13485
• others as applicable