risk-analysis, DIN 14971, risk-management, medical-devices
Risko analysis, DIN 14971, Risk management Medical devices, In-Vitro-Diagnostics, IVD DEUTSCH | IMPRINT 08.09.2010 FDA notification, CE-marking, EN 1441 Qware Riskmanager
risk-analysis, DIN 14971, risk-management, medical-devices
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harmonized norm DIN EN 14971
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Likelihood and severity evaluation after measuresPartner
DIN EN ISO 14971:2000
assignment with DIN EN ISO 13485_2003Articles | Reports | News
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directive 93/42/EWG risk evaluation and for risk control
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In-Vitro-Diagnostics IVD FDA authorization CE-marking

Risk management for medical devices and in-vitro-diagnostics in laws, regulations and standardisation

In the German, European and American law for medical products there is agreement about the demand of a risk management for medical products and in-vitro-diagnostics. The flow of the risk management process is elucidated in the international norm DIN EN ISO 14971. This norm will displace all previous regulations after a period of change.

Risk management as pilot for the application of resources saves time and money

Risk management is an interactive and partially also recursive process because the insights in possible risks grow with deepened knowledge about product structures which are gained in the course of development. The earlier you gain these insights the less time and money will be wasted on wrong ways. Within this lies the biggest source for savings.

Wrong ways do not only cost time and resources which are normally scanty measured anyway. They also cause the hazard that they will be overlooked in case of a tardy discovery of potential risks under the pressure of actual or alleged inherent necessities. Therefore here applies the rule that it might be better to invest a bit more in the beginning – and this in a documented way – to achieve a more favourable overall result (costs, time to market, admissions, life cycle costs).

But it is not only for the detection of potential risks at an early stage. As manufacturer you need a comprehensible benchmark, to keep the expenses for development and admission of the products in a prudential proportion to the benefit which can be expected. This benchmark is delivered by the risk management. All identified risks will be assessed and a portfolio of risks will be created as a body axis system with the determinants “possible extend of loss” and “probability”.

The classification of risks according to benchmarks which you have to determine and represent yourself should clear evidence where and with which intensity the resources have to be put in to reach your aim in the most efficient way. The same counts for the development of products itself as well as for successful tests, efforts of verification and validation and the documentation. Of course, the minimum requirements which are prescribed have to be fulfilled according to the classification of the MP or the IVD. Furthermore there will still be a significant scope of discretion which can – guided by a documented risk management – be scooped for the benefit of the client and manufacturer.

Process of risk management

The first step is the identification of potential hazards which can be caused by functions or processes. All identified reasons of hazards will be assessed. For the assessment a portfolio method will be disposed.

Subsequently a body axis system with self-defined terms, criterias of classification and typical examples for the probability of the appearance of the reasons and their potential extend of loss will be created. The area, which will be stretched from this axis system is subdivided in rectangular areas through the definition of the axis intercept.

The company policy regarding the acceptance of risks is determined trough a green-yellow-red deposit of the rectangles according to traffic lights. In the light of the assessment all identified risks will be allocated to a certain area. Now everybody can see at the first sight where a call for action exists.

Process of a risk management which accompanies the development

5 phases of development

The process of a risk management which accompanies the development runs parallel through the chosen lifecycle model regarding time and content. Already in the first phase, in which the requirements for the product will be defined the risk management joins the process. This process is by all means comparable with activities regarding the creation of value, which also join the process at this stage accompanying to the development. Also the creation of value provides sustainable and better results than the value analysis at the completed product.

The analysis of risks (risk analysis) which takes a look at the at this stage only roughly specified functions/processes of the product, provides you with first hints on possible solutions which should be further pursued and also with hints which should be better not taken into consideration at all. Beside the actual product functions the attention will be directed to the avoidance of potential risks. By this, absolutely new and maybe even better ideas for the realization can be created. First measures in construction area can be realized (risk control).

Because this happens at a point at which the investment in work and money is very low (in comparison to the overall expenses), all insights are especially valuable. Wrong ways can be avoided; the available strengths will be deployed reasonably where the biggest benefit can be expected.

Documentation of results

With the help of appropriate tools (e.g. Qware® Riskmanager) all results will be saved and documented systematically. This helps you especially regarding similar products for which you can use these insights again. You can use existing projects easily as initial point for new considerations out of the data base as pre-occupancy for a new project. The only part that remains is the new part in the project.


Find possible solutions

After the release of this phase of the lifecycle you will change from this stage to the next one, in which the requirements will be realised in possible solutions and their specifications. Also in this phase the analysis (risk analysis) and assessment (risk evaluation) of potential risks takes place accompanying.

Through refinement of the specifications and the analysis of technical solutions arise new insights and notional associativities for the product and the risk management which have to be used. New measures for avoidance or reduction of risks appear – maybe you even have to make one step back to implement the new results in an optimal way.

Nevertheless it is worth while because only a small part of the overall expenses has still been invested. The well-known “tenner rule” for the cost for realisation and correction of mistakes which means that the cost increase from phase to phase about the factor ten is a good clue. The most expensive is – which is evident to everybody – the product recall from the market which entails also the cost for the image loss which is besides hardly to numeralise.

Detail work and realisation of the product

A further phase follows in which the design, the specifications and the risk management will be detailed.
The technical realisation of the product follows in the next phase of the life cycle. This step accompanies the management of measures for avoidance and reduction of the risk (risk control).

This measure management continues in the following test phase of the product life cycle. Everything has to be documented of course; especially at this point the right tools save a lot of work.

When the product has been released for commercialisation also the risk management inclusively documentation will be closed for the time being. The risk management file which is required in ISO 14971 has to be available at this point of time.

Working in the insights in the records

Insights for product adjustment out of the initial batch - which have to be expected only marginally after a good preparatory work – have to worked in into the records of development and risk management. They have to be verified and validated where necessary.

After admission (e.g. CE labelling) and release from the manufacturer for commercialisation the phase of market observation starts. All identifiable new risks which result from the market observation have to be included in the risk management. In the worst case they case recall actions with grave financial consequences and an image loss. Should damage to persons or property arise, the risk of liability claims is coming along. This should actually not occur in case of a risk management which has been accomplished in a responsible and accurate way.

(Published in MTD Medizin-Technischer Dialog 10/2000, p. 34-38)

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