ISO 13485 Certification
Medical Devices Quality Management System
What is ISO 13485?
ISO 13485 is the globally recognized standard for Quality Management Systems in the medical device industry. It provides a regulatory framework to ensure the consistent design, production, and delivery of safe and effective medical devices.
This standard applies to medical device manufacturers, suppliers, and distributors, ensuring compliance with industry regulations. Certification enhances product reliability, regulatory approval, and customer confidence.
Benefits of Certification
01
Increased Product Safety
Ensures medical devices meet quality and safety standards.
02
Regulatory Compliance
Facilitates compliance with medical device regulations worldwide.
03
Market Access
Opens opportunities in global healthcare markets.
04
Enhanced Risk Management
Reduces product defects and improves reliability.