ISO 13485:2016

ISO 13485:2016 is the internationally recognized standard for quality management systems (QMS) in the medical device industry. It provides a framework for manufacturers and organizations to ensure consistent design, development, production, installation, and delivery of medical devices that are safe and effective for their intended purpose.

Why ISO 13485:2016?

• Regulatory Compliance:
• Quality Assurance
• Market Access
• Continuous Improvement

Benefits of ISO 13485:2016 Certification

• Enhanced product quality and safety
• Improved operational efficiency
• Increased customer satisfaction and trust
• Reduced risk of legal and regulatory issues
• Better supply chain management and relationships

With years of experience in the medical device sector, our team of skilled auditors offers comprehensive certification services. We are dedicated to helping organizations achieve and maintain ISO 13485:2016 certification with minimal disruption to their operations.