EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 14971 testing. This standard specifies terminology, principles and a process for risk management of medical devices, including software as medical devices and in vitro diagnostic medical devices.
The process described in this document is intended to assist medical device manufacturers in identifying medical device-related hazards, predicting and evaluating associated risks, controlling those risks, and monitoring the effectiveness of controls.
The requirements of this document apply to all phases of a medical device's lifecycle. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and system security, electrical, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not required to be medical devices in some jurisdictions and may be used by others involved in the medical device lifecycle .
This document does not apply to:
This document requires manufacturers to establish objective criteria for risk acceptability, but does not specify acceptable levels of risk.
Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.
Guidance on the implementation of this document can be found in ISO/TR 24971 .
EUROLAB assists manufacturers with ISO 14971 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
