Vitrolife’s quality system conforms to international standards and local regulations for the medical device and pharmaceutical industries.

Conformity of regulatory requirements

The quality system is process-oriented and the continuous improvement work involving the two main processes (order to sales and product life management cycle) includes activities such as identifying critical process interfaces, monitor key performance indicators and regularly review all sub levels of the organisation in order to optimise the efficiency of the processes.

The Vitrolife quality system has been audited and approved according to:

Approved quality system

Vitrolife is regularly audited by external authorities from all over the world such as Notified Bodies (EU), Food and Drug Administration (US), Therapeutic Goods Agency (Australia) and Medicines Product Agency (Sweden).

The requirements and audit methodology varies from country to country, but Vitrolife’s quality system has proven to be dependable and accepted through numerous external audits during more than a decade.    

By having an approved and validated quality system our customers can be confident that the products provided by Vitrolife are thoroughly controlled. Our dedication to support clinics to be successful and to provide quality all the way to the patient is a cornerstone in our work.