We have been working on it for a long time and it has finally become a reality. At Certest Biotec, leader in the development of in vitro diagnostic products, we have obtained the EU Quality System Certificate according to Regulation (EU) 2017/746, Annex IX, Chapters I and III for a total of 46 of our products, corresponding to more than 575 catalogue references. This important achievement reinforces our commitment to quality, safety and regulatory compliance.
This certification, the result of months of work, guarantees that our products meet the most rigorous standards in the industry. To achieve this, we have spent months working closely with the global leader in testing, inspection and certification services, TÜV Rheinland, to align all our internal processes with the requirements of the IVD Regulation. This includes updating technical documentation, improving quality management systems and implementing new post-market surveillance measures.
It should be noted that this certificate is in addition to the various certifications that Certest holds in the field of quality and social commitment.
This achievement reinforces our commitment to our customers, distributors, end users and patients to provide them with products of the highest quality, efficacy and safety, while, in the words of our CEO, Nelson Fernandes, “it allows us to significantly improve our processes, giving us the opportunity to continue working every day to be the biotechnological reference that we have become in these more than 20 years of effort and work”.
