a capability within quality management

Advisory Service and Guidance

Creating business value is at the core of what we do in the Quality Management team at Technolution. When advising our clients, we always make sure to balance the business side with the process and documentation side. With this mindset we can guide your organization to make smarter decisions regarding the setup of your quality management system.

Our team can assist your organization with:

  • Professional sparring on finding the best approach to regulatory compliance based on your specific business organization, e.g. separate country locations.
  • Guidance on how to navigate within regulatory requirements before certification or re-certification, such as ISO 9001, ISO 13485, IVDR, MDR.
  • Guidance about the impact of new regulations and their effects on the business and organization.
  • MDR and IVDR compliance related to new product classification.
  • Analysis and assessment of the current state of your Quality Management System and suggestions for improvements.