Risk Management for Professional Users of Medical Devices and In Vitro Diagnostic Medical Devices


Well established methods with a new name?

The European health care system is in the crisis and therefore a lot of reforms and new guidelines are published to ease the trouble a little bit. But what are these new methods described in the actual statements and guidelines? Isn't it a well known principle of medicine? For example Quality Assurance is practised by the medical doctors since many years! Is this again a trial of getting non-suitable technical methods realized in medicine?

Actually the idea of Risk Management is nothing new! Every time a medical doctor is checking the risk of his therapy against the advantage for the patient. But to be honest: Did You ever see a documentation of this Risk Management Process?

There is no need for argumentation about the sense of this documentation which is demanded in different regulatory coming from national legislation, health insurance scheme or hospital management.

Systematic procedures save time and money

Risk Management is not only a regulatory duty, it can optimize the effectiveness and internal transparence of Your organization. The only question is, how to realize?

Best would be a method simple and easy to understand to be multiplied in Your organization. This method is well known by now in the US for years and know also establish in a few economic fields.

The advantage of the method is the continuous subjective proceeding in analysis and assessment. The subjective data is not transferred in "objective" figures as usual in other methods. The result presentation of the assessment is realized using only subjective and easy to understand colors.

You are interested? You need a little assistance in realization of Your Quality and Risk Management System? consulting & more will have a look on Your individual situation to develop the needed processes together with You.