ISO 13485: Medical Component Manufacturers


DEKRA has transformed ISO 13485 certification into an opportunity for you to improve your company’s efficiency and thus increase profits.

As many countries require this certification, it can open up new markets around the world. We can help you comply with ISO 13485. We align our audit plan with your business goals and thus help you achieve your management objectives. When your facility is due for a quality system audit, the ISO 13485 enables you to combine the quality system requirements with the regulatory requirements.

In order to justify the processes involved in the development, production, design, and servicing of medical devices and in vitro diagnostic devices, medical device companies have to implement a quality
management system. Most often, QMS requirements are met using the ISO 13485 standard, which
has been derived from ISO 9001. ISO 13485 is an internationally recognized and harmonized QMS
standard, developed especially for medical device companies in order to provide guidance and tools to
create an effective quality management system to ensure product and service quality.


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