ISO 13485: Medical Component Providers
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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Management system certification is offered by DEKRA Certification, Inc., which operates independently from any consulting and training activities using the DEKRA brand.