ISO 13485 Registration

Quality Management System for Medical Devices

What is ISO 13485?

ISO 13485 is an international standard for Quality Management Systems (QMS) specifically designed for organizations involved in the manufacturing, supply, and servicing of medical devices. It ensures safety, regulatory compliance, process consistency, and continuous improvement.

Objectives

✓ Ensure quality and safety of medical devices
✓ Meet regulatory and legal compliance
✓ Reduce manufacturing risks and errors
✓ Enhance customer and patient trust

Who Needs ISO 13485?

Medical device manufacturers

Medical equipment suppliers and distributors

Clinical laboratories

OEM producers

Healthcare equipment handlers

Steps to Obtain ISO 13485

Conduct Gap Analysis
Define Quality Policy and Objectives
Prepare QMS Documentation and SOPs
Implement & Train Staff
Conduct Internal Audit
External Audit by Certification Body
Receive Certification

Required Documentation

✓ Company registration documents
✓ Quality Manual and SOPs
✓ Device testing and validation records
✓ Supplier and customer records
✓ Internal audit and corrective action records

Duration & Cost

Duration: Approximately 3 to 6 months. Cost varies depending on company size and certification body.

Benefits

✓ Global acceptance in medical device industry
✓ Helps win tenders and international approvals
✓ Improves product quality and reliability
✓ Increases customer satisfaction and trust