We are your experienced partner for the risk management of medical devices. We support you in all risk management relevant topics within the scope of your product development or during the life cycle of a medical device in accordance with the requirements of the MDR.
A special focus is placed on the clinical risks in connection with the use of the product. All documents are reviewed and approved in cooperation with a medical specialist. Our qualified team consists of risk managers, medical specialists, nurses, MTAs, specialised engineers and regulatory affairs experts.
Minimise with our risk management for medical devices together with us
the design or product related difficulties of your product.
the design or product related difficulties of your product.
Risk Processes
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Creation of risk processes according to EN ISO 14971 and FDA criteria
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Adapt existing processes
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- We also adapt existing processes to the conditions of the MDR according to EN ISO14971 or create a completely new process together with you. Here, special attention is paid to other process areas such as user requirements, usability, clinical evaluation and post market clinical follow up (PMCF). We can also adapt these processes if necessary.
Risk Management Plan
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Plan and build according to 'Intended Use' of the product
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Adapt existing processes
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- We design and create a product and intended use specific risk management plan for our clients. This includes:
- Definition of all risk-specific aspects of the corresponding product.
- Risk graph with severity and probability of occurrence with corresponding acceptance criteria.
Risk Analysis
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Define the hazards and the hazardous situation as well as the product-specific possible patient harm.
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Determine the severity of possible patient Harm (Harm List)
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Calculating the probability of possible patient harm (occurrence)
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Create a product specific risk graph and risk analysis
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- We draw up a list of specific hazards and hazardous situations, including the possible resulting harm to patients. In addition, the severity levels of the possible patient harm (Harm List) are determined by an experienced medical specialist. Usually, these severity levels are assumed to be the most severe (worst case) patient harm. In practice, however, these most severe harms rarely occur. We represent the different degrees of severity by a cascading impairment definition (Harm). For a clear presentation of possible patient harms, the following contents are included:
- Harm groups with the respective gravity lines.
- Severity levels and their medical consequences.
- Probability of occurrence of possible patient harm (calculated from clinical experience and clinical literature).
- A product specific risk graph.
- A complete risk analysis is also possible within the framework of our risk management for medical devices. In particular, the application-specific risks are listed by a clear clinical definition of the respective application steps. These application steps result from the clinical context in which the product is used.
Risk Management Report
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Summarise the results of the risk analysis in accordance with the risk management process and the risk minimising measures defined in this process.
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Create a risk benefit analysis
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Establish Post Marked Clinical follow up (PMCF) activities
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Creation of a Safety Assurance Case (SAC) specifically for US products in accordance with FDA 510 [K]
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- The risk management report summarises the results of the entire risk management process. This decision preparation is based on the risk analysis and the defined risk-minimising measures.
- We perform a risk benefit analysis based on the clinical evaluation and product risks.
- Possible and necessary post market clinical follow up (PMCF) activities are also defined.
- A Safety Assurance Case (SAC) specific to US FDA 510[K] products can also be prepared.
- All corresponding documents are reviewed and approved by an experienced clinical user (usually a medical specialist). This complies with requirements from the MDR. Our team consists of people from different professional groups – from risk managers and nurses, to medical specialists and MTAs, to specialised engineers and regulatory affairs experts.In this way, we are able to develop interdisciplinary solutions for the risk management of medical devices for our customers.
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Gladly we are at your disposal for any questions!
