What is ISO 13485:2016?
ISO 13485:2016 is an internationally recognized standard that
specifies the requirements for a Quality Management System (QMS) tailored for
organizations involved in the medical device industry. This standard places a strong
emphasis on ensuring the safety and effectiveness of medical devices throughout their
lifecycle. Organizations adhering to ISO 13485:2016 commit to implementing processes
that cover design, development, production, installation, and service, with a keen focus
on meeting both customer and regulatory requirements.
Benefits of ISO 13485:2016 Certification:
- Enhanced Product
Quality: Implement robust processes to enhance the design, development,
and manufacturing of medical devices, ultimately leading to superior product
quality.
- Customer Confidence:
Demonstrate your commitment to delivering safe & effective medical devices,
building trust with customers, healthcare professionals, and regulatory bodies.
- Risk Management:
Prioritize patient safety by identifying and managing risks throughout the
product lifecycle, from design to post-market activities.
- Regulatory Alignment:
Align your organization with global regulatory requirements, ensuring
compliance in key markets and facilitating international trade.
- Global Recognition:
ISO 13485 is globally acknowledged, opening doors to new markets and
demonstrating a dedication to quality on an international scale.
