ISO 13485 – Medical Devices Quality Management
- Industry: Pharmaceuticals & Medical Devices
About ISO 13485
ISO 13485 is the internationally recognized quality management system (QMS) standard specific to medical device manufacturers and suppliers. It outlines requirements for the consistent design, development, production, installation, and servicing of medical devices while meeting regulatory and customer requirements.
Why ISO 13485 Certification Matters
- Regulatory Alignment: Required or accepted by regulatory bodies in major markets, including the U.S., EU, Canada, and Japan.
- Product Safety and Consistency: Ensures controls are in place to reduce risk, support product quality, and maintain traceability.
- Customer Trust: Demonstrates commitment to quality and regulatory compliance—vital for hospitals, healthcare providers, and OEM partners.
- Market Access: ISO 13485 is often a prerequisite for entering global supply chains in the medical device industry.
EAGLE’s ISO 13485 Auditing Services
We conduct rigorous audits to help you meet ISO 13485 requirements and prepare for certification. From design controls to risk management and post-market surveillance, our experienced team supports you every step of the way.
Benefits of Our Auditing Approach
Expertise:
Our auditors possess deep industry knowledge and understand the nuances of your unique needs.
Tailored Solutions:
We customize our auditing approach to fit your organization's specific needs and operational context.
Partners in Success:
We pride ourselves in becoming your partner in achieving your objectives while taking a consultative approach.
Contact us today to begin the process and take the first step toward achieving certification.