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 30 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.

Areas of expertise:

Quality-Audit offers medical device consulting on the following compliance related tasks:

• ISO 13485:2016
• MDR (Medical Device Regulation 2017/745)
• MDSAP
• MDD 93/42/EEC
• 21 CFR part 820

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