Compliance with risk management requirements for medical devices
ISO 14971, Medical devices - Application of risk management to medical devices, details the risk management principles and practices as referenced in a number of key medical device standards, including the 3rd edition of IEC 60601-1 (electrical safety), ISO 13485 (quality management systems), IEC/EN 62366 (Usability of medical devices), ISO 10993 (biological evaluation) and IEC 62304 (medical device software). As such, compliance with the provisions of ISO 14971 is essential for manufacturers of medical devices seeking regulatory approval in the U.S., the European Union (EU), Japan, Australia and other major international markets.
Risk management for medical devices
The risk management process presented in ISO 14971 includes:
- Identifying hazards and hazardous conditions associated with a medical device that could place patients or healthcare workers at risk.
- Estimating the potential occurrence of such risks, and evaluating the extent of the consequences.
- Developing and implementing active safeguards within the device or the production process to control risks.
- Regularly reviewing and monitoring the process to assess the effectiveness of risk management controls and the risk management process.
Each aspect of a risk management system is thoroughly documented to provide evidence of the manufacturer’s commitment to control risk throughout the entire life of a given medical device design.
A robust risk management system can also provide important value by supporting the development, production and distribution of all types of new medical devices. Products under development are subject to greater scrutiny early in the design stage. This allows for the identification and implementation of changes and modifications to improve functional safety and usability with minimal impact to the product development schedule. For certain types of medical devices, an effective risk management evaluation will also identify risks associated with device reprocessing and reuse. These and other benefits can result in faster time to market, and greater competitive advantages.
Why choose TÜV SÜD
TÜV SÜD’s industry specialists and clinical practitioners are experts in the review and assessment of risk management systems and supporting technical documentation, and have extensive experience in the auditing of risk management systems. In addition, TÜV SÜD Product Service is recognised by regulatory authorities throughout the world for its technical and regulatory expertise in medical devices, and is familiar with the regulatory requirements for medical devices in major medical device markets.
Our services at a glance
- Risk management expertise - TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971, and conduct thousands of in-depth risk management audits each year.
- Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices. Testing for device usability and functional safety are also available.
- GLP compliant biocompatibility evaluations - TÜV SÜD laboratories conduct biocompatibility tests in compliance with GLP Principles.
- FDA 510(k) third party review service - TÜV SÜD Product Service has participated in the FDA 510(k) third-party review program since its inception in 1996, and offers third-party submission reviews for over 600 devices. TÜV SÜD Product Service medical device experts maintain close contact with FDA reviewers to ensure that issues are promptly addressed, resulting in a more efficient review process and timely product clearance.
- Other testing and certification services - In addition to the assessment of risk management systems required for medical device manufacturers, TÜV SÜD Product Service can also provide compliance testing for medical devices in accordance with other relevant regulations and standards, including IEC 60601-1 and electromagnetic compatibility (EMC).
Your benefits at a glance
- Recognised medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Centre of Excellence, TÜV SÜD Product Service is recognised by regulatory authorities around the world for its extensive experience with all types of medical devices.
- Quality system certification and auditing expertise - Medical device approvals routinely require the implementation of a quality management system. TÜV SÜD conducts quality management system certifications, audits and factory inspections consistent with most international regulations and standards. TÜV SÜD clients can enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs.
- Active involvement in standards development and implementation - TÜV SÜD Product Service technical professionals are actively involved in standards development activities related to medical devices, and participate in a number of key standards committees. TÜV SÜD Product Service is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on standards and regulations applicable to medical devices.