RISK MANAGEMENT
YOUR TASK: minimize the risks
A carefully-conducted risk analysis in accordance with EN ISO 14971 can already significantly improve a medical device's safety, even while it is still in the development phase. Consequently, potential risks associated with the device can be identified and minimized by taking appropriate measures.
YOUR Challenges
We focus on your demands.
Are you aiming to CE-mark your medical device and must set up a Risk Management file?
Do you need updated Risk Management files according to MDR?
Has your Notified Body detected any deficiencies concerning your clinical data or PMS activities that also affect your Risk Management documentation?
Are you looking for support in Regulatory and Clinical Affairs?
Do you need additional human resources to support your Risk Management?
Are you looking for external know-how and independent expertise?
YOUR BENEFITS
We have been working in the field of Regulatory Affairs and particularly Risk Management since 2004. Benefit from our years of experience.
We use templates which have been developed based on the EN ISO 14971, the requirements of Regulation (EU) 2017/745, and our experience with Risk Management. However, we will also work using your own SOPs/templates on request.
Our team supports you in various areas of Risk Management: Facilitation of RM team meetings, interface-considering preparation and updating of Risk Management documentation with all required documents. If required with regard to clinical data, we help you with medical expertise.
RISK MANAGEMENT AT A GLANCE
According to your requirements, our activities include one or more of the following steps.
1
Project kick-off
First we define the scope and strategic approach together with you and agree on a time frame including any deadlines that need to be met. This is followed by the exchange of all necessary information.
2
Risk Management Plan
A Risk Management Plan (RMP) is drafted according to the latest requirements. If an RMP is already in place, it is updated according to the lifecycle phase and updated requirements which apply to the medical device. (Interface to Clinical Evaluation, Post-Market Surveillance)
3
Hazard analysis
Hazards are identified based on existing data (State of the Art in technology for intended purpose, e.g., from standards, literature, and experience with own products, predecessors, similar products or competitors).
4
Risk analysis
Based on the hazards previously identified, hazardous situations are evaluated, including their potential harm. Severity and probability of occurrence of these potential harms are estimated, and the resulting risk determined. These risks are compared to the risk acceptance criteria established in the risk management plan and categorized as either acceptable, as low as reasonably practicable, or unacceptable.
5
Risk control
Risk control measures are defined and discussed, taking into account the order established in the ISO 14971: design, alarm, and, as a last resort, safety information. One or more of these risk mitigating measures are then implemented by the manufacturer.
6
Evaluation of residual risk
After successful implementation of the risk control measures, risks are re-evaluated regarding their severity and probability of occurrence. The remaining individual residual risks are again assessed by applying the criteria for risk acceptability. The individual residual risks have been minimized as far as possible and are assessed as acceptable or unacceptable.
7
Overall Benefit/Risk analysis
At the end, the benefit-risk analysis is performed, in which the individual risks in the overall residual risk are compared to the overall benefit with regard to the intended purpose. (Interface to the Clinical Evaluation)
Based on the benefit-risk ratio, a product can either be considered safe to use and can be commercialized, or it can be considered as unsafe, safe under certain conditions, etc. (Interface to the Technical Documentation)
8
Risk Management Report
Based on the Risk Management Plan and summarizing the Risk Management activities, a final report is generated.
(Interface: Clinical Evaluation, Post-Market Surveillance, activities for customer/patient information)
Contact our experts!
Do you have any further requests?
SOP-Update
We show you how to align your processes and SOPs MDR- and standard-compliant and to make them more efficient.
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GAP Analysis
We thoroughly review your Risk Management file. If desired, we offer you our tried and trusted templates.
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Post-market updates
We keep your Risk Management file up to date regularly or whenever necessary or support your team in doing so. In the process, we focus on consistency with your Clinical Evaluation and the PMS.
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Risk Management-Training
We keep your team updated to the latest version of ISO 14971 and all legal requirements (e.g. MDR).
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Moderation of the RM-Meeting
We guide you through the organization and conduction of your team meetings regarding Risk Management activities during product development or after commercialization.
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Medical expertise
Our medical experts are glad to help in case you need any medical expertise.
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