«It is no use saying, 'We are doing our best. ' You have got to succeed in doing what is necessary.»

Together with you, we develop easily usable and effective organisational structures and processes, integrated into a management system that meets all the requirements of Medtech or Healthcare. We provide our organisational work in a comprehensive project or selectively, entirely according to your needs.

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We ensure the success of change management with specific measures focussed on the employees in all phases of change management, the unfreez, moving and refreezing phases. We also apply Deming's Plan-Do-Check-Act quality management approach.

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ANALYSIS

• Conduct staff surveys, customer surveys and interviews (online/ face-to-face)

• Determine the current organisational situation

• Carry out risk analyses with regard to the company and its processes

• Provide requirements from the strategy work

• Conceptualise management system

 

DEFINE STRUCTURES & PROCESSES

• Form organisational structures

• Develop company processes

• Documenting the management system (quality system, QMS)

 

IMPLEMENTATION

• Train employees

• Active support in the implementation of new/changed structures, processes and corporate culture

• Support managers and employees

 

FURTHER DEVELOPMENT

• Carry out internal audits​

• Accompany audits of the certification body and customer audits

• Support in quality data evaluation and preparation of quality reports/ management review

• Optimise/ expand organisational corporate culture, structures, company processes and management system

 

In our organisational work, we implement the following legal and normative requirements of Medtech:

• ISO 9001, ISO 13485 or EN 17025

• FDA 21 CFR part 820 Quality Management System Regulation QMSR

• Swiss Code of Obligations (esp. ICS)

• Swiss Medical Devices Ordinance MepV 812.213

• EKAS directive 6508 on safety at work

• European Medical Devices Regulation 2017/745 MDR

• Medical Device Single Audit Program MDSAP

 

We develop the management systems in accordance with the St. Gallen Management Model according to Rüegg-Stürm & Grand.