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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)
- MDD 93/42/EEC
- 21 CFR part 820
Our mission: Participate in our customers’ business success by helping them meet or exceed compliance.