medlaQ | Consulting for medical devices

technology consulting

Particularly during development of In vitro-diagnostic medical devices you can choose from several technological approaches available.

As a result from orienting proof-of-principle studies techniques offering the most promising features, the highest reliability, the maximal sensitivity and the optimal specificity are pre-selected. However proof-of-principle studies does not necessarily generate unambiguous outcomes. This uncertainties may be problematic to your company because it may cause avoidable wrong decisions.

In case that you outsourced development tasks to an external party it may be expedient to monitor and to assess these activities and the corresponding results critically in order to generate positive development outcomes and in order to keep the costs within the budget.

Therefore a second opinion by the view on your product during development from the outside may be helpful and eventually may circumvent wrong decisions and increase of project costs. Exactly this is the experience I made repeatedly in my professional life.

Of course I cannot guarantee you that my opinion will solve your problem. However I surely can contribute to lead you out of this delimma.

medlaQ - Consulting for medical devices

Dr. Bernhard Gerstenecker

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