In line with its commitment to making safe and effective IVD and medical devices available worldwide, regulatory affairs firm Arazy Group Consultants Inc. is assisting MedTech manufacturers in meeting the deadline to upgrade their quality management systems (QMS) to the ISO 13485:2016 standard.
MedTech firms have until February 28, 2019 to transition their quality management systems from the ISO 13485:2003 and the EN ISO 13485:2012 standards. However, it is recommended that firms start planning their transition as a matter of urgency and that it is completed by early 2018.
Arazy Group is ensuring its clients’ procedures meet the latest ISO requirements, enabling them to obtain premarket approval for their products in 100+ countries across the globe both quickly and cost-effectively. Furthermore, as part of its service, it offers quality assurance professionals a two-hour training session on the implementation of the changes.