top of page

ISO 13485 for Medical Device Manufacturing

Brought to you by IBEC Intelligence

ISO 13485 is the world’s most widely used standard for a Quality Management System (“QMS”) for the design and manufacture of medical devices. ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, but it is designed for regulatory compliance and it is more prescriptive in nature and requires a more thoroughly documented quality management system.

ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

Benefits of ISO 13485 Certification

A well-run operation with processes under control leads to financial rewards for your hard work and investment in the Quality Management System. QMS certified companies have shown improvements in financial performance as compared to uncertified ones. An ISO 13485 QMS can help your organization to:

· Improve your company’s credibility and image

· Expand market access

· Improve customer satisfaction

· Improve your processes and performance

· Increase efficiency and reduce cost of sales

· Improve product safety

· Improve decision-making process

· Create a culture of continual improvement

· Better employee engagement

· Meet regulatory requirements

How to Get ISO 13485 Certified

By creating your QMS using the ISO 13485 requirements, you can ensure that you have a world-class system for meeting the needs of customers and regulators for your medical devices. ISO 13485 provides you with more than the bare minimum to meet the legal requirements; it provides a whole system that is devoted to help you improve your quality processes.

To know more and get information on what's the best way to get ISO 13485 certification with minimal investment and maximum rewards schedule a free 30-minute consultation with an IBEC expert.


bottom of page