MEXACARE PASSES MAIN-AUDIT SUCCESSFULLY
MEXACARE proved once again that the highly sensitive production processes, the entrepreneurial management and the quality approval requirements of the German diagnostics company, which are becoming increasingly strict according to the IVDR, were passed by the independent notified body without any major deviations.
The major main audit is valid for 3 years and the CE certificate is therefore secured for the German and European market.
Despite an extreme growth phase in 2021, all regulations were met to ensure consistent quality as a German manufacturer of rapid diagnostics.
The regulatory hurdles for the IVDD directive will be tightened in 2022, so MEXACARE GmbH has already proven that it is prepared for the further stricter rules and can look to the coming financial years with confidence.
„MEXACARE GmbH is subject to regular, strict controls of its entire quality management system, which is certified according to DIN-ISO 13485:2016. As part of the annual review by the certified MDC, we had already successfully completed the annual surveillance audit in September 2021 without any major deviations from the requirements required by the standards. MEXACARE was thus very well prepared for the changes to the new IVD directive and the 3-year main audit that had just been passed with full re-certification as a manufacturer of in-vitro diagnostics,“ says Lutz Rothe, Managing Director of MEXACARE GmbH.
In terms of personnel, MEXACARE GmbH has invested in 3 more highly qualified employees and has grown in the regulatory area and is professionally positioned to cope with the increased requirements of the regulatory approval process.
All the quality management documents requested were transparently presented to the auditors of the approval supervision and all processes, as well as studies, approval data and the detailed documentation were presented.
“Every single internal and external process is put through its paces and even a minor deviation can have serious consequences for the continued existence and development of the company. As a German manufacturer, we are particularly proud that the independent inspection authority has approved us as an ISO 13485-certified manufacturer of diagnostics for the next 3 years without a major deviation, so that we were once again able to prove our valued quality and reliability to our customers and business partners,“ says Knut Butzinger , CEO of MEXACARE GmbH.
This DIN ISO 13485:20216 main audit, which lasts several days, corresponds in principle to the granting of a „new“ manufacturer license and includes, among other things, the detailed and most precise review of the product developments, the manufacturing process, the review of the clinical studies and the individual approvals through to the detailed review of the concluded contracts with service providers and partners.