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 GOAL

We focus on your needs.

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 Clinical Evaluation since 2004. Benefit from our years of experience.

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Our templates were developed based on our experience with clinical evaluation according to MEDDEV 2.7/1 Revision 4 and adapted to the requirements of Regulation (EU) 2017/745 as well as MDCG 2020-1, MDCG 2020-5, MDCG 2020-6 and MDCG 2020-13. Upon request, we are also happy to work with your SOPs/templates.


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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

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. In this phase, we will exchange all necessary information.

2

Risk Management Plan (RMP)

An initial Risk Management Plan (RMP) is drafted and the level of risk is determined. If an RMP is already in place, it is updated according to the lifecycle phase and update requirements which apply to the medical device.

3

Risk control

Risk control measures are defined, including residual risk assessment.

4

Risk/benefit analysis

Finally, there is a risk/benefit analysis of the individual risks.

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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