Quality for Medical Devices

Medical device manufacturing is a highly regulated sector, in which significant quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce and place onto the market medical devices that are safe and fit for their intended purpose.

Quality at ABLE Human Motion

Implementation of ISO 13485

 

At ABLE Human Motion, we believe in continuous improvement and we have implemented and certified a Quality Management System in compliance with ISO 13485. You can find our certificate here .

 

ISO 13485: 2016 is the medical device industry’s most widely used international standard for quality management. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

European Regulation MDR 2017/745

 

We are developing our first product, the ABLE Exoskeleton, in compliance with European Regulation MDR 2017/745 and we expect to obtain the CE certification in the following months.

 

The implementation of the QMS according to ISO13485 will serve as the basis for the CE certification according to European regulations. The standard is also used as a reference in the Medical Device Single Audit Program (MDSAP) and as such can be leveraged for compliance with the requirements of Canada, US, Japan, Brazil and Australia.

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