Contact us: +49 (0)251 590 657 67
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?
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.
Hazards that could affect the medical device are identified based on existing data (e.g. from own products, predecessors, similar products or competitors).
Based on the hazards previously identified, hazardous situations are evaluated, including their potential harm.
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.
Risk control measures are defined, including the assessment of residual risk.
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.
Finally, there is a risk/benefit analysis of the individual risks.
The final report is generated based on the risk management plan, the risk analysis as well as its successful implementation.
We show you how to align your processes and SOPs to avoid redundancies and having to collect data and perform analyses multiple times.
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.
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.
We keep your team updated to the latest version of ISO 14971 and all legal requirements (e.g. Regulation (EU) 2017/745).
We guide you through the organization and conduction of your Team-meetings for risk analysis and evaluation.
Our medical experts are glad to help in case you need any medical expertise.