Services

Provide a holistic approach, in the industries of semiconductor and medical devices, to help our customers to accomplish their goals in the areas of:

Quality management
Regulation driven programs, projects management and PMO infrastructure
IT and information system programs requirements definition, roll-out and implementation
Operational excellence through people mentoring

Medical Device Quality Management

Specializes in Quality and Regulatory activities management in medical device companies per ISO13485, EU MDR and FDA QSR, particularly in Quality System Management establishing and implementing.

Includes process improvement and procedure writing.

Project Management

Program/Project management in a methodological and structured manner, with special focus on medical device and regulated industries. Adjusting the methodology and tools to the customer's environment, company agility and project characteristics. Where needed, we also aim to teach employees how to manage their own projects and to institutionalize optimized and easy to use PMO infrastructure.

Our services include documenting processes and implementing them across organizations.

IT Management

IT and information system activities and program management from customer and business requirements definition, scope and version management, program execution supervision and roll-out to users

Operational Excellence

Managing and leading is about operational excellence, continual imprvoement and people leadership. For these to become the company's way of life, part of its DNA, it is not enough to deploy methods and tools but to work hand-in-hand with leaders . Coming from the world of engineering management we are able to mentor in a pragmatic and sensitive manner.