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

Winston Churchill

 

CONSULTING

COMPANY ORGANIZATION, QUALITY MANAGEMENT AND REGULATORY AFFAIRS CONSULTING

Our consulting is process oriented, effective and leads you to easy results in quality management and regulatory affairs.

 

Examples of services we have done our customers:

  • Definition and optimization of the organizational and operational structure

  • Establish, maintain and optimization of quality management systems

  • Accompaniment in the development and certification of medical devices

  • Establishing of the technical file for medical devices

  • Feasibility studies and investigations for new medical devices

  • Due-Diligence checks concerning QM/RA prior to company take-over and investment

  • Risk analysis (concerning company, products and processes)

In our consulting we follow the following laws and standards:

  • ISO 9001, ISO 13485 or EN 17025

  • Swiss Code of Obligations (specifically Internal Control System)

  • Swiss Medical Device Ordinance MepV 812.213

  • EKAS Directive 6508 for safety at workplace

  • Regulatory Affairs according European Medical Device Regulation 2017/745 (former 93/42/EEC)

  • European Machine Directive 2006/42/EC

  • FDA 21 CFR part 820 Quality System Regulation