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 NEEDS
We focus on your demands.
Do you need an updated Clinical Evaluation according to current regulations?
Has the Notified Body revealed any deficiencies concerning your documentation?
Are you planning to obtain a CE-mark for your medical device for the European market?
Are you looking for regulatory and clinical affairs support?
Do you need additional human resources?
Are you looking for external know-how and independent expertise?
YOUR BENEFITS
We have been working in the field of Regulatory Affairs and specifically Risk Management since 2004. Benefit from our years of experience.
We use templates which have been developed based on our experience with Risk Management, the ISO 14971 and the requirements of Regulation (EU) 2017/745. However, we will also work using your own SOPs/templates on request.
Our team supports you in risk analysis in various areas: Facilitation of RM team meetings, preparation of risk management documentation with all required documents, including risk management plan, risk analysis, risk assessment, risk management report and FMEAs and if required, we help you with medical expertise.
RISK MANAGEMENT AT A GLANCE
According to your requirements, our risk analysis activities include the following steps.
1
Projekt Kick-off
2
Risk Management Plan (RMP)
3
Risk estimation
Hazards that could affect the medical device are identified based on existing data (e.g. from own products, predecessors, similar products or competitors).
4
Risk analysis
Based on the hazards previously identified, hazardous situations are evaluated, including their potential harm.
5
Risk evaluation
The potential risk of every hazardous situation is estimated regarding severity and pobability of occurrence. It will then be assessed using the criteria for risk acceptability defined in the Risk Management Plan.
6
Risk control
Risk control measures are defined, including the assessment of residual risk.
7
Residual risk evaluation
After the successful implementation of the risk control measures, risks are re-evaluated regarding their severity and probability of occurrence. The remaining risk will again be assessed by applying the criteria for risk acceptability.
8
Risk/benefit analysis
Finally, there is a risk/benefit analysis of the individual risks.
9
Risk management report (RMR)
The final report is generated based on the risk management plan, the risk analysis as well as its successful implementation.
Get in touch with our experts!
Do you have any further requests?
SOP-Update
We show you how to align your processes and SOPs to avoid redundancies and having to collect data and perform analyses multiple times.
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GAP Analysis
We thoroughly review your Risk Management File. Depending on your individual needs, we either work with your templates or use our tried and trusted ones.
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Post-market updates
We keep your Risk Management File up to date whenever neccessary. In the process, we especially 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. Regulation (EU) 2017/745).
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Moderation of the RM-Meeting
We guide you through the organization and conduction of your Team-meetings for risk analysis and evaluation.
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Medical expertise
Our medical experts are glad to help in case you need any medical expertise.
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