ISO 13485 2016 Medical Device Quality System Standards

1. ISO 13485:2016 allows your organization to meet the customer requirements in the
production of medical equipment.
2. Provides necessary ideas to standardize quality management in the medical equipment
fields.
3. Certification will reduce or eliminates FDA audits
4. Well built QMS for medical devices help avoid the need to recall medical devices
5. Well-built ISO 13485:2016 QMS shows the way to adhere to all statutory and regulatory
requirements associated with medical devices.
6. Certified ISO 13485:2016 companies produce good quality medical devices which help
extend human or animal life expectancy
7. Critical in providing a competitive edge for your organization
ISO 13485: 2016 certification specifically addresses the way companies implement management
strategy that focuses on products that are safe and effective. The new standard requires a higher level
of responsibility to be in the hands of management by laying out detailed guidelines to create a stronger
quality management system (QMS) and process based approach which define, implement, and improve
effectives of quality management system that they expected by customers and regulatory requirements.
URS India has been holding itself up to these standards for a long time prior its application for
certification. The practice of quality management and control is deeply ingrained in our company culture
and in the way we develop our medical devices. With a closed-circuit operation where we can oversee
and work closely at all levels of design and production, there are less unknown variables that might
compromise quality or safety.