ISO 13485 Certification
Your Challanges
A product or organization operating without ISO 9001 certification can face several challenges, which can affect the quality, customer satisfaction, and overall business performance. As a business ……, you to want guarantee the success of your transformation journey.
How we support/help you
We partner with you to bring your innovative products to market, ensuring they are safe, perform to specifications, and meet environmental regulations.
What is ISO 13485?
ISO 13485 is Quality Management System for Medical Devices. ISO 13485 is applicable to designers, manufacturers, and distributors of medical devices. The standard contains the requirement for quality management systems, to meet customer requirement and incorporate applicable regulatory requirements within an organization’s quality management system.
Key Aspects of ISO 13485
Standard name
ISO 13485:2016
Purpose
The primary purpose of ISO 13485 is to establish a robust quality management system (QMS) specifically designed for the medical device industry. The standard aims to ensure that medical devices are consistently designed, developed, manufactured, and delivered to meet both regulatory requirements and customer expectations.
Benefits of ISO 13485
Certification Process
The certification process consists of 3 basic phases:
Life Cycle
| Previous | Now |
|---|---|
| ISO 13485:2003 | ISO 13485:2016 |
