ISO 13485:2016
Medical Devices Quality Management System

ISO 13485 Certification is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series.

ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment.
ISO 13485:2016 ensures that medical devices used in healthcare settings are designed, produced, installed, and serviced to the highest standards. As any business owner knows, these standards must not only meet client obligations, but also regulatory and legal specifications.

Adopting ISO 13485:2016 into the heart of your practices means you will build a clear, practical foundation to address these specifications, as well as demonstrate a commitment to safety, quality, and competence.

Benefits to Business

1. Evidence-based decision making
2. Taking control of your supply chain
3. Ensuring control processes are robust in every step of your product’s life
4. Reducing costs through a more efficient QMS
5. Becoming up-to-speed with the needs of regulatory authorities in your area
6. Less Waste

Benefits of Certification

1. Qualified with an internationally-recognized certification
2. Higher Customer Satisfaction.
3. Higher Prestige
4. Increasing Marketplace
5. certification also demonstrates that your management system complies with the international standard
6. Embed internationally recognized Food Safety Management processes in your business
7. Demonstrate a commitment to quality processes and continual improvement
8. Expanding Market To International Level
9. Strengthen your brand and get access to top retailers