The establishment of the design controls is one of the most important aspects of the ISO 13485 certification, since, it describes the route to follow in the direction to start and maintain the quality management system. Understand and implement the quality plan, according to the applicable government requirements such as FDA 21 CFR 820, etc. The ISO standard requires that the consultant must be experienced in your sector/industry-specific business. Selecting one partner consultant for all your locations saves time and money. This stage involves the preparation of the quality plans for implementing changes to your quality management system.

Therefore, it is more prescriptive in nature and requires a more thoroughly documented quality management system. The ISO 13486 certification is designed for regulatory compliance. It considers that the Quality Management System is appropriate and effective while emphasizing the safety and efficacy of medical devices. The ISO 13485 Certification involves the establishment and implementation successfully of the ISO 13485 Quality Management System.

It is a third-party certification that demonstrates to regulators that you have met the requirements of the standard.

In this article, you will learn what is the ISO 13485 Certification.

Iso 13485 fda