... comprises all measures for systematically detecting, analyzing, evaluating, monitoring, and controlling risks. It is understood as a process of continuous planning, implementation, monitoring, and improvement.
... should begin BEFORE you start product development. By defining all risks together with your team at the beginning, considering and organizing them for risk management, we eliminate all obstacles at an early stage. And it saves you a considerable amount of time and money for a subsequent implementation of necessary measures.
... is our specialty, because our engineers and natural scientists have extensive knowledge and many years of experience with the development of medical devices and their regulatory requirements.
EN ISO 14971: Application of risk management to medical devices
Both the medical device regulation and different harmonized standards require a risk management process. EN ISO 14971 describes a process for the application of risk management to medical devices. The standard offers a procedure enabling the manufacturer to identify, assess, and control the risks linked to its medical device.
Our services relating to EN ISO 14971
- Organizing workshops and seminars to train your team: Tailored exactly to your needs, we discuss your individual questions together.
- Moderating risk analyses: Your team has the product-specific expertise, we take care of the timely implementation of risk analysis.
- Developing and optimizing the risk management process: Risk management is a central component of your quality management system. We take care that the process is efficiently integrated into your system.
- Integrating the risk management results into the technical documentation: We ensure that the risk management is appropriately linked to the other parts of your technical documentation.
- Verifying risk management measures: For your risk management measures you do not only have to prove that they have been implemented properly, but also that they are effective. We are happy to support you in planning and implementing your verification measures.
The risk management file
The risk management file as an element of the technical documentation documents all activities that are planned and executed in the context of risk management. For you as the manufacturer it is documented proof that you completed all required activities.
Our risk management file services
- Preparing the risk management file consisting of:
- Risk management plan,
- Preparation and moderation of risk analyses,
- Risk assessment and development of risk-reducing measures,
- Verification of measures, their effectiveness and traceability,
- Risk management report.
- Assessing existing risk management files against current standard requirements and implementing new requirements.
- Identifying and analyzing non-conformities in risk management and developing possible improvements in the scope of the existing QM system.
- Adapting the risk analysis throughout the entire product lifecycle.
Facing challenges with a smile
True, the requirements for you as a manufacturer are enormous: The EU agrees on a new medical device regulation (MDR) in nearly no time and leaves manufacturers with an interim period of no more than three years to lift all medical devices to MDR level. MEDDEV 2.7/1 revision 4 increases the planning pressure on manufacturers: The notified bodies call for updated clinical evaluation already. And the ideas for software as a medical device often seem to be well ahead of its documentation. Knowing that there is a partner at your side with comprehensive know-how and many years of experience with the documentation and approval of medical devices and IVDs along with their verification and validation, there is no need to worry. We are committed consultants and service providers. Together we make your project a success.We look forward to getting to know you!