«The best way to predict the future is to create it.»

We take on interim functions and become involved in your company in a goal-orientated and professional manner. We familiarise ourselves with the subject matter in the shortest possible time and contribute our knowledge and experience.

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We are very familiar with the following functions:

• Head of Quality Management

• Head of Organisation/ Corporate Development

• Quality Engineering

  

We work within your management system and ensure compliance with the following laws and standards:

• Quality Management Systems according ISO 9001, ISO 13485 or EN 17025

• Swiss Medical Device Ordinance MepV 812.213

• EKAS Directive 6508 for safety at workplace

• European Medical Device Regulation 2017/745 MDR

• FDA 21 CFR part 820 Quality Management System Regulation QMSR

• Canadian Medical Devices Conformity Assessment System CMDCAS

• Medical Device Single Audit Program MDSAP