We are proud to announce that Astra Biotech Biotech has demonstrated full compliance during its audit. The audit was performed under Regulation (EU) 2017/746, Annex IX, Chapter I (Initial Certification, Draft 32398), and the DIN EN ISO 13485:2021.
This achievement is more than just a regulatory requirement; it is a testament to our unwavering commitment to the highest quality standards in human diagnostics. By aligning our Quality Management System with the rigorous new European regulations, we ensure that our partners and customers can continue to rely on the safety, precision, and excellence of our solutions.
We are excited to continue our journey of bringing cutting-edge diagnostic tools to the market.
