Titan Medical Inc. announced receipt of ISO 13485 Certification from a European Notified Body following completion of audits of the Company’s quality system and related documentation. This certification represents that Titan’s quality management system (“QMS”) maintains standards that meet international requirements specific to medical device design and development. ISO 13485 certification is the most common path to meet the QMS medical device requirements in the European Union, Canada and Australia, and serves as the basis for QMS compliance in other countries including Japan, Korea and Brazil. Titan also announced the achievement of its two other previously stated milestones during the fourth quarter of 2019: The Company obtained the final independent report from its validation testing of system safety and usability for the intended users and use environments under simulated robotic manipulation exercises, which are intended to replicate essential surgical tasks; and The Company completed the robotic system setup user manual for operating room staff and surgeon operation of the surgeon workstation, patient cart, instruments and accessories.