Independent, professional and discreet consulting services for the medical device industry.

Quality-Audit is a Danish privately owned consulting company founded in 2019 by Gert Sørensen.

Quality-Audit has specialised in auditing and assisting Medical Device companies in meeting the US & European regulatory and Quality Management System requirements.

Since 2019 Quality-Audit has assisted more than 20 companies – ranging from start-ups to truly global companies – with their audit and compliance challenges.

Quality-Audit can assist your company through interpretation of the regulatory requirements relevant for your medical device and offers a range of services help you.

Our mission: Participate in our customers’ business success by helping them meet or exceed compliance.

We deliver our services to more than 30 well known an
acknowledged companies world wide