PRIMA Lab SA is committed to developing and manufacturing high quality, reliable products and services in the field of in vitro diagnostics for both self-testing and professional use in the human and veterinary fields.
PRIMA Lab SA Quality Management System is compliant with ISO 9001:2015 and EN ISO 13485:2016 requirements. All these certificates have been issued by mdc (Medical Device Certification).
The new In Vitro Diagnostic Medical Device Regulation (IVDR) came into force on May 25, 2017 and was applied on May 26, 2022. We implemented quality procedures to comply with the EU IVDR requirements (e.g., Vigilance, Post-Market Surveillance requirements, PRRC) that are in force from the IVDR application.
PRIMA Lab SA’s Quality and Regulatory departments are committed to giving our customers and partners the best support in this transition. In the light of the recent implementation of the Reg. EU 2017/746 (IVDR) and given the importance and strategic impact of this Regulation on our business, we would like to share some key points about the PRIMA Lab SA transition plan to IVDR 2017/746:
Our mission is to give you the best support to face the regulatory challenges emerged in the market!