ISO 13485:2016
Certification
Medical devices — Quality Management Systems
ISO 13485 is an internationally recognized quality management system (QMS) standard specifically designed for medical devices and related services. It is published by the International Organization for Standardization (ISO) and provides a framework for organizations to ensure compliance with regulatory requirements for medical devices.
Streamline legal and regulatory requirements in multiple countries
Enhances product safety and reliability
Improves credibility and trust in medical device products
Streamlines processes and reduces risks
Supports compliance with MDR (EU), FDA (US), and other global standards
Why Should Your Company Have ISO 13485 Certification?
ISO 13485 certification is essential for companies in the medical device industry as it ensures compliance with international regulations, improves product quality, and enhances credibility with customers and regulatory authorities. It provides access to new markets, reduces operational risks, and strengthens process efficiency. By obtaining this certification, companies demonstrate their commitment to safety and reliability, minimizing product recalls and non-conformities. Additionally, it helps build trust among clients and partners, offering a competitive edge in the industry. Investing in ISO 13485 certification is a strategic decision that contributes to long-term business growth and sustainability.
QMS and the ISO 13485 Certification
Integrated
Management
QMS offers a wide range of ISO certifications, making it easier for companies to streamline integrations of medical devices quality management system with other management systems
Agile
Process
We have a structured, validated, and constantly improved process on an international level. This process streamlines communication, question resolution, scheduling, and certificate issuance
Qualified
Auditors
QMS has highly qualified ISO 13485 auditors who have been auditing medical devices for many years
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