ISO 13485 Certification
Your Challanges
An organization operating without ISO 13485 certification in the medical device industry may encounter significant challenges, including difficulties in meeting regulatory requirements, ensuring product safety and quality, and building customer trust. The lack of a structured quality management system can result in inefficiencies, non-compliance penalties, and potential product recalls, all of which can harm business performance and reputation
How we support/help you
At TCMS, we specialize in supporting organizations in the medical device industry to meet the stringent requirements of ISO 13485, ensuring your products are safe, effective, and compliant with regulatory standards.
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 |
