As every year, an audit by TÜV Rheinland took place at DiaSys in November. Everything was different this time, as the audit had an extended objective.
From November 15 to November 24, 2021, TÜV Rheinland audited DiaSys and its subsidiaries DiaSys Deutschland GmbH, DiaSys Technologies Sarl and pes diagnosesysteme GmbH. In addition to the re-certification audit for DIN EN 13485:2016, the auditing according to IVDR, the new European In-vitro Diagnostics Regulation and the MDSAP audit for the countries Brazil, Japan and USA were also scheduled. With this objective, the Quality Management and Regulatory Affairs (QM/RA) department faced a particular challenge, especially since it was necessary to obtain all three certificates within the scope of a single audit.
Compared to previous audits, this time the scope differed in particular in the preparations. Already weeks before, a comprehensive documentation audit was carried out by TÜV Rheinland.
Not only the QM/RA department was greatly challenged. All DiaSys employees had to focus on this audit for many weeks and transfer process descriptions into our new QM software Consense. In addition, technical documents for the conformity assessment of the first products under the IVDR were already provided to the TÜV. These were also created in new software in order to be able to transmit them digitally to the notified body in the future and to maintain their life cycle more easily.
All these efforts were followed by a great success of which we are very proud. We have successfully achieved the certification for DIN EN 13485:2016, the certificate according to MDSAP for the countries Brazil, Japan, and USA as well as the QMS audit regarding the IVDR requirements.
Now we can continue the lengthy process of bringing all our products under the new IVDR: We will keep you, dear customers and partners, informed.