The requirements of ISO 13485 are applicable to all medical device organizations regardless of size, type and structure. ISO 13485 is beneficial for many organizations, as it is used by suppliers, as well as external parties that are involved with providing medical device products and services.
Third party review of an organization’s quality management system provides internal and external verification to customers of the monitoring, measurement and control of your processes, as well as builds confidence to meet applicable regulatory requirements. The standard is set to strive for continual process improvement and quality performance, as well as time and cost savings after implementation of this standard.
Organizations that are involved in one or more stages of the life-cycle, from design and development to production, storage/distribution, installation, or servicing of medical devices, benefit from our medical team’s expertise in quality management. As a valued partner, we ensure transparency and clarity throughout the audit process.
Together with DQS Medizinprodukte GmbH (DQS Inc.’s holding), DQS Inc. is proud to offer MDSAP certification services, along with DIN EN ISO 15378 and DIN EN ISO 13485 under DQS Med as the notified body.
While DQS Inc. strives to create a safer world, ISO 13485 supports the reduction of unexpected risks and enhances management of those risks in order to meet the company’s desired goals. This enhancement not only increases the organization’s reputation in the eyes of their customers, but also includes a practical and effective solution to demonstrate a commitment to the regulatory requirements.