Quality management – made in Germany

Beatrice Schroetter QM Consulting from Hagenbach offers practically relevant support in all concerns around quality management according to ISO 9001 and ISO 13485 medical devices with profound pharmaceutical expertise at a high level. From the implementation of your QM system right through to certification you will be guided and coached through the whole process.

Professional practice shows that the daily business of a quality manager faces various skills. Behind Beatrice Schroetter QM Consulting means vast international experience raised from various industries: product development, process improvement, manager of production consumer electronics, quality management medical devices just as well as project management in the pharmaceutical industry.

Besides the daily safeguarding of the customer´s requirements, audits have to be planned and carried out, processes have to be re-designed or to be adapted to regulatory requirements – not to mention the regularly reporting to the board. The competition is tough, the authorities relentless and the certification according to ISO 13485 necessary. Beatrice Schroetter QM Consulting stays by your side competently and flexibly, if processes have to be re-designed, audits to be carried out or if you just need support in your projects. Beatrice Schroetter QM Consulting follows the DMAIC and the PDCA-Cycle and relieves the strain on your company`s resources.

Quality support will assist your company during the ongoing QM process in handling peaks and outsourcing processes to enhance effectiveness and save costs. Duration and scale of operations can be chosen flexibly and following your demand.

Quality Consulting is focussed on consulting and professional support in all concerns of QM for medical devices or project leadership in design transfer pharmaceuticals/medical devices.

Quality Tools trace the consequent utilization of the quality tools to enhance both quality and efficiency.