From May 17 to 20, 2022, the 27th edition of Hospitalar took place at São Paulo Expo. In this edition, which was marked by the post-pandemic resumption, we have the support of Anbiotec (National Association of Biotechnology and Life Sciences).
During the four days of the fair, we were present at stand D-128 and walking around the fair, where we were able to see customers and create new partnerships.
On Thursday, the 19th, our CEO Márcio Henrique Lacerda Arndt presented at Arena Health a lecture on 'Good Manufacturing Practices for Medical Software', where he discussed what medical software is, its categories, how to regularize a medical software factory, RDC No. 665/2022, which provides for good manufacturing practices for medical products and diagnostic products for In Vitro use, RDC No. 657/2022, which provides for the regularization of software as a medical device of classes 1, 2, 3 and 4 and the applicable international standards, RDC nº 10/2015, which provides for the regulation for conducting clinical trials with medical devices in Brazil, CNAEs for framing and a successful case of Enzytec: the work of the Regulatory Affairs sector to our client Predikta, where we carry out all the regularization of the factory.
We were immensely happy to have filled Arena Health with people so interested in the subject and we had the pleasure of being able to talk to several listeners who came to us at the end of the lecture. It's always a pleasure to talk about Regulatory Affairs, simplify what can often seem complex and collaborate so that new companies appear and grow in Brazil with everything in order!
Do you need support in your company for Regulatory Affairs? Get in touch with our team of experts!