A medical device is any product used for diagnose, prevent, or treatment of a medical condition. Medical devices can be basic health products used to cover or protect a wound, or dentist chairs, pacemakers, vital support machines, and even in-vitro diagnostic reagents.
4. Quality Management System
5. Management Responsibility
6. Resources Management
7. Product Manufacturing
8. Measurement, Analysis, and Improvement
ISO 13485 requirements are applicable to any organization, independently of size, type or location except where explicitly stated otherwise. When the requirements are specified as applicable for medical devices, the given associated services are equally applied by the organization.
*Exclusions are allowed in the management system with a proper justification whenever the applicable regulatory requirements allow it.
Audit under GlobalSTD methodology
These are some benefits:
To demonstrate the regulation requirements compliance.
To increase customers and consumers trust.
To improve process and quality in production.
To ensure medical devices in compliance with necessities and industrial needs.
Certificates issued in the world
Certificates in USA, leading country in ISO 13485
Sites certificated worldwide
*Numbers of ISO Survey 2016.
The certification process pays attention to every detail making sure that the company duly complies with all the standard’s requirements.