ISO 13485:2016 Medical Devices Quality Management Systems

What is ISO 13485:2016?

ISO 13485:2016 is an international standard for quality management systems designed specifically for the medical device industry. It helps manufacturers and suppliers meet regulatory requirements and ensure that medical devices are designed and manufactured safely.

BESA Consulting Scope

• Current state analysis and GAP assessment
• Design and development process structuring
• Risk management (ISO 14971) integration
• Supplier evaluation and audit processes
• Internal audit and management review
• Certification body application and audit support

Benefits

• Ease of compliance with EU MDR/IVDR and FDA regulations
• Strengthened product safety and traceability
• Access to international markets (CE, USA)
• Quality assurance across the supply chain