ISO 13485 Certification – Quality Management System for Medical Devices

ISO 13485 is an international standard for quality management systems (QMS) specifically designed for the medical device industry. Its primary goal is to ensure the safety, effectiveness, and regulatory compliance of medical products by helping manufacturers establish consistent and reliable processes.

What is ISO 13485?

ISO 13485 outlines the requirements for a QMS covering the entire lifecycle of medical devices, including design, production, installation, and post-market servicing. It emphasizes a process-based approach, risk management, and regulatory compliance throughout all operational stages.

Key Requirements of ISO 13485

• Establishment of a comprehensive QMS covering the full product lifecycle
• Maintenance of documented procedures and technical documentation
• Ongoing process monitoring, data analysis, and continuous improvement
• Risk management integrated at every stage
• Full traceability of medical devices

ISO 13485 Certification Process

1. Application submission and offer preparation
2. Contract signing with the certification body
3. Optional preliminary audit (Stage 0)
4. Certification audit – Stage I (document review) and Stage II (on-site audit)
5. Issuance of certificate
6. Annual surveillance audits

How Long Does Certification Take?

The ISO 13485 certification process typically takes 1 to 3 months, depending on the size of the company and complexity of its processes.

Does ISO 13485 Help with CE Marking?

Yes – compliance with ISO 13485 supports the quality management system requirements outlined in MDR/IVDR, helping facilitate the CE conformity assessment process.

Does ISO 13485 Replace Other Certifications?

No – it does not replace other certifications but can support and complement regulatory compliance across multiple jurisdictions.

Why Choose GCB for ISO 13485 Certification?

• Extensive experience in the medical device industry
• Transparent and consistent certification process
• Customized support tailored to client needs
• Highly qualified and objective auditors

Benefits of ISO 13485 Certification

• Compliance with international regulations
• Improved safety and quality of medical devices
• Increased trust from customers and business partners
• Enhanced risk management capabilities

Risks of Not Implementing ISO 13485

• Restricted access to EU and other key markets
• Lower product quality and increased risk of medical incidents
• Lack of process control and traceability
• Loss of trust from customers and stakeholders