Quality Assurance
Research and developement

Quality Assurance

Our certified quality management system gives our customers reassurance and ensures a high quality, covering all aspects of our services

Efficient cooperation

Technolution is certified according to ISO 9001: 2008 and ISO 13485: 2012. Our certification and our experience in working within our clients’ quality systems make the cooperation with certified businesses efficient.

Furthermore, Technolution is able to offer implementation of quality management systems in new businesses.

Technolution’s consultants are experienced in bridging regulatory demands, the creativity of the R&D departments and quality management.

ISO 9001:2008

ISO 9001 focuses on clients’ needs and continuous improvement of business performance through the requirement of continuous improvement of products, services, processes and systems.

ISO 13485:2012

ISO 13485 focuses on quality management in the development and manufacturing of medical devices. This includes requirements for risk management and documentation.

Technolution’s quality management system is also in compliance with the following standards:

  ISO 14971:2012 Medical devices – Application of risk management to medical devices
  IEC 62366:2007 Medical devices – Application of usability engineering to medical devices
  ISO 15378:2012 Primary packaging materials for medicinal products

Scope of Technolution quality management system:

ISO 9001/13485 certificationISO 9001/13485 certification
Click here to see our ISO 9001/13485 certification.

Services

  • Application of Technolution QMS (Quality Management System)
  • Review
  • Risk Management (ISO 14971)
  • Audits
  • Business Processes (development and optimization of procedures, instructions and forms)
  • Usability Engineering (DS/EN 62366)
  • Verification and Validation

References

For further information

Michael Tokeskov Mikkelsen

PROJECT MANAGER