Our product quality is underpinned by our quality management system, which takes into account the requirements of the International Organization for Standardization (ISO) devices, the European medical legislative requirements (Directive 93/42/EEC and Regulation 2017/745), the US FDA Quality System Regulations for medical devices (21 CFR part 820), the Japan MHLW Ministerial Ordinance No.169, and other regulations in our target markets.