Knoten

«You can't tie a knot with just one hand.»

Mongolian wisdom

MARKUS RAMSEYER

Freelance employee

Education and Training

  • Degree in Mechanical Engineering University of Applied Sciences - Specialized in medical technology, development and project management in the field of infusion and injection technology

  • Post-Graduate Degree in Business Administration

 

Work Experience

Markus Ramseyer worked as a development engineer, department and development manager in a company for infusion and injection technology from 1991 to 1996.

In 1996, together with a business partner, he founded his own company where products for pharmaceutical companies and medical technology firms were developed and produced.

Since 2003 he has been working with his own company vision focus GmbH as a consultant in the area of development, quality management and product approvals for national and international clients.

 

Specific Expertise and Experiences

  • Project management of entire systems (hardware-software-mechanics-optics)

  • Technical documentation

  • Approval procedures and conformity assessments for EU, US and CA

  • Development and maintenance of quality management systems according to ISO 9001, ISO 13485, QSR and CMDCAS

  • Quality management systems for the distribution (GDP) and wholesale (GMP) of medicinal products

  • Installation and operation of clean rooms

  • Risk management

  • Product and process validation

  • Validation of sterile medical devices (gamma, ETO, humid heat)

  • Mechanical, electronic and software development

  • RFID technology

  • Auditing

  • Due diligence and expert assessments for authorities and pharmaceutical companies

  • Trainings and seminars

 

Auditor Qualification

Freelance auditor for Swiss Safety Center AG (former Swiss TS Technical Services AG) for quality management systems according to ISO 9001 and 13485.