Titan Medical Inc. has 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.
SO 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 Medical has 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.
- 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.
“We are pleased to have achieved these previously stated milestones during the fourth quarter of 2019, especially given the financial challenges we have recently faced,” said David McNally, president, and chief executive officer of Titan Medical. “In recent weeks we exercised our $35 million common stock purchase facility with Aspire Capital to fund our work while we continue to seek additional financing.”