German Medtech startup DiaMonTech has received the official certification for medical device manufacturers from the International Organisation for Standardisation (ISO) for its non-invasive blood glucose measurement tool.
ISO 13485 is designed to help medical device companies demonstrate safe and ethical design and development. To receive certification, organizations must demonstrate that their Quality Management Systems deliver medical devices that consistently meet customer and regulatory requirements.
The certification is considered to be the initial step for DiaMonTech to qualify for the Medical Device Directive (MDD) process in the European Union and paves the way for further development in the startup’s plans to deliver handheld and wearable health monitoring devices.
Source: Mobihealthnews
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