The requirements for medical device manufacturers are constantly increasing worldwide. Hospitals and health facilities expect functional and low-risk medical devices, while patients must be able to rely on the safety of the equipment. Manufacturers are therefore facing enormous challenges in market launch and the subsequent process of maintenance and risk management.
Our experts support you throughout the entire process and value creation chain of your medical devices with numerous services in quality- and risk management. Our experts advise and support you during the development and approval of your medical product. In addition, we help you with the market launch and the commissioning. We always keep the costs in mind and we ensure that your products are functional and low-risk – for the entire lifetime of the device and beyond.
With our support in the development, market launch and low-risk operation of medical devices, you
Our experts would be pleased to respond to any questions or requests for more information about the manufacturer's service for medical devices.
As part of your risk management, we accompany you throughout the entire process and value creation chain of your medical devices. Thanks to our many years of experience, we know the target markets and national requirements, as well as the various types of devices and their market behavior. The quality and safety of your equipment is thus assured.
Our experts support you in the various stages with the following services:
We accompany you in managing all the processes around your risk management system. We thus ensure the quality and safety of your medical devices and ensure each one gains approval.
Furthermore, we assist you in monitoring the risk-benefit profile and identify possible product risks in the context of the impartial and independent market monitoring.
Our experts support you in implementing all technical testing and safety criteria required to ensure the reliability, functionality and the effectiveness of the data- and system security of medical devices that are in operation.
For this purpose you can access our technical laboratories and extensive servicing network of the TÜV Rheinland offices worldwide.
To operate medical equipment successfully, national and international policies, legal provisions and normative standards are of the utmost importance.
Relevant standards for medical devices include, for example, IEC 62353, IEC 60601, IEC 80001, ISO 13485 and ISO 14971.
Legislation and regulations such as the Medical Products Act, the Medical Devices Operator Ordinance, the German Ordinance on Industrial Safety and Health and the French Décret n° 2001-1154 of 5 December 2001 are also of great importance for medical device manufacturers.