Auditors at LCS LLP hold an ISO 17025 “Testing and calibration laboratories” internal auditor certificates and ISO 13485 “Medical devices – Quality management systems. Requirements for regulatory purposes.” training certificates and the certificate "Development and implementation of quality management systems and compliance with the requirements of ST RK ISO 9001-2016".
In addition, employees of our company have extensive national and international experience in the regulation of medical devices, in particular, in the field of laboratory quality control. Large number of medical device manufacturer audits was carried out in various countries of the world. Company employees also participated in the preparation of a testing laboratory for entry into the network of European official medicines control laboratories (OMCL).