MedqTech konsult

We work as Regulatory and Quality Advisors, Project Managers and/or act as a resources in your organization.

Do you need help in getting started to work with the new medical device regulation MDR 2017/745 or IVDR 2017/746 in Europe?

Are you ready to meet the requirements of ISO 13485:2016 or do you need a Senior Lead Auditor to perform an Internal Audit on your Quality Management System?

Do you need support in your Risk Management Process or perhaps it is time for customized education with your company? We are experts in ISO 14971.

Do you need support in the regulatory registration process for your Medical Device? We can help.

From the swedish west coast

It doesn´t matter where you are, we can still be of assistance. We use modern technologies and the digital world to easily work anywhere.

The office is located on the west coast of Sweden, strategically between Oslo and Gothenburg.

Our mission is to provide our competence in the field of Quality and Regulatory Compliance and to offer practical and sustainable solutions for our customers, to continuously meet the regulatory requirements in the EU as well as USA.

Consulting company focusing on assignments in medical technology.

References

"Therese has been very professional and thorough at each point of engagement and her expertise in this area is outstanding."