ISO 13485:2016 Certification

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.