Ensuring Quality and Safety for Medical Devices
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.
Your Benefits at a Glance
With our support in the development, market launch and low-risk operation of medical devices, you
- get an impartial and periodic review of your medical devices.
- have a strong and technically savvy partner at your side.
- minimize the risk of product liability.
- are assured your patients can rely on the safety of your equipment.
- get independent and impartial feedback from experienced experts on the suitability and performance of your equipment.
- improve your company's image by having your devices tested by the globally recognized ‘TÜV Rheinland’ brand.
- achieve a lower accrual ratio for work or services covered by the warranty.
Our experts would be pleased to respond to any questions or requests for more information about the manufacturer's service for medical devices.
Our Services for Your 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:
- Product development
We identify potential risks of your products and create extensive documentation on them.
Our experts ensure that your medical devices comply with the normative and legal requirements. We also support you in regulatory matters.
- Market launch
To ensure your market launch goes smoothly, our staff can help to integrate your medical devices into health care systems on the ground.
For a smooth start-up, we perform an initial operation check and offer in-house training. We also draw up the documentation.
- Operation / maintenance
During operations, our experts can carry out tests under the German X-ray Ordinance (RöV). Technical safety and metrological testing can be also carried out. Taking into account applicable risk management standards, together with you we also develop a maintenance management plan and conduct impartial market monitoring.
We support you with a comprehensive fault analysis and re-investment analysis. Corresponding product improvements can be derived later from the results.
Safety and Risk Management
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.
Legal Basis for Medical Devices
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.