ISO 13485
Certification
Certify with confidence—achieve ISO 13485 for medical device quality and compliance
What is ISO 13485?
ISO 13485 is the international standard that specifies requirements for a quality management system (QMS) for organizations involved in the design, production, installation, and servicing of medical devices. It focuses on ensuring the consistent design, development, manufacture, and delivery of safe medical devices that meet both customer and regulatory requirements.
Key Features of ISO 13485
- Based on ISO 9001 principles but tailored specifically for medical devices
- Emphasizes risk management and process control throughout the product lifecycle
- Addresses regulatory compliance for global markets, including FDA, EU MDR, and other authorities
- Covers documentation, traceability, supplier management, and post-market activities
- Supports continual improvement of medical device quality and safety
Why ISO 13485 Certification Matters?
- Required by regulatory agencies worldwide for medical device manufacturers
- Enhances product safety, reliability, and customer confidence
- Facilitates market access and acceptance in global healthcare sectors
- Helps reduce risks related to product recalls, defects, and noncompliance
- Demonstrates commitment to quality and patient safety
Who Needs ISO 13485?
- Medical device manufacturers and suppliers
- Contract manufacturers and testing labs
- Companies providing installation, servicing, or distribution of medical devices
- Organizations seeking to meet regulatory and customer requirements in healthcare
Steps to ISO 13485 Certification
- Understand ISO 13485 requirements and implement a compliant QMS
- Conduct internal audits and management reviews
- Address gaps and nonconformities through corrective actions
- We audit and certify
- Maintain certification through ongoing compliance and surveillance audits
ISO 13485 Certification Services
Accelerate Compliance with Trusted ISO 13485 Certification Support – Our ISO 13485 certification services provide end-to-end support to help medical device companies achieve and maintain compliance with global regulatory requirements. From quality system implementation to audit readiness, we guide you through every step of the ISO 13485:2016 certification process.
Ready to be certified?
Contact us today for us to audit and certify that you meet the international standards requirements of ISO 13485