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. This means that when advising and guiding organizations about e.g. meeting regulatory requirements or challenging the status quo regarding the client’s Quality Management System, we always make sure to balance the business side with the quality side. If e.g. production resides in another country than sales, 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 different opportunities that match your business approach to become compliant with regulatory requirements.
  • We can support you with guidance within regulatory requirements before certification or re-certification, such as ISO 9001, ISO 13485, IVDR, MDR.
  • Guide about consequences regarding new regulations and its effect on the business and organization.
  • Guidance regarding the structuring of your Quality Management system across e.g. different country locations in a way that is most fitting to your business.
  • 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.