ISO 13485 Medical Devices QMS
ISO 13485 Medical Device QMS is based on the ISO 9001 process model approach. This framework is specifically designed for medical device manufacturing companies. ISO 13485 was integrated to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes.
It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.
Why you need ISO 13485 in your company?
- Improved systematic process
- Improved commitment to high quality
- Improved global recognition
- Improved Decision Making & Involvement of Top Management
- Higher chance for financial benefits
- Enhanced Customer Satisfaction
- Improvement in employee involvement can be observed
- Ability to contract with larger companies
- Potential market expansion
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