medlaQ | Consulting for medical devices

quality management

medlaq Qualitätsmanagement

Your business processes are inefficient and susceptible to failure?

In order to generate optimal results the business processes of your company ideally should be taylored to your particular requirements. Releveant process norms like ISO 9001 and ISO 13485 request the installation of an continuous improvement process requiring to monitor, document and improve your processes.

If applicable key performance indicators are used which are monitored and assessed periodically. The key performance indicators should be adequate to the importance and criticality of the respective process as well as to the size of your company.

You should use only a few key performance indicators but assess these consequently and regularly. If necessary you should take appropriate corrective actions.

Often insufficiently defined or even undefined organizational interfaces may cause susceptability of your processes for failure. But also insufficient regulation of tasks and responsibilities may cause problems with your processes.

By my many year’s experience with manufacturers of medical devices and also by my detailled knowledge of development, manufacturing and quality control processes I certainly can help you.

medlaQ - Consulting for medical devices

Dr. Bernhard Gerstenecker

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