Portugal-based PeekMed has received ISO 13485 certification for its 3D pre-operative system and can now sell the system all over Europe, according to an August 31, 2017 declaration from the company. The system had already received CE mark approval.

ISO 13485 is a globally agreed standard that sets out the needs for a quality management system exact to the medical devices industry. It has lately been revised, with the new version published in March 2016. The standard is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing procedures.

João Pedro Ribeiro, PeekMed's CEO, said the CE mark approval and ISO certification achievements permits the company to provide surgeons with tools that assist them with "more rigorous and objective planning, making the surgery more predictable, actual, and safe for the patient." The company develops, produces and markets medical software technology that provides more predictable patient treatments, presently focusing on orthopedic treatments.

In a 2016 press release, the company claimed that using PeekMed, a surgeon can decrease up to 20% of the surgery time and growth the accuracy of the team by analyzing the patient’s lesion in different angles. The hospital can decrease the sterilization costs in average 50% per surgery.

The current declaration said the company lately released an updated version of its system focused on a new design and new features. The inventive system, PeekMed v2.0, according to the company, now is seamlessly combined with the first 3D mobile app for pre-operative planning in the orthopedic field. It allows the orthopedic surgeons to “plan faster, safer and easier than ever.”

The company is working on FDA 510(k) clearance for the U.S. market and claims the system is used by more than 700 users worldwide.

PeekMed was founded in 2014 by Ribeiro, Sara Silva and Jaime Campos. The trio launched what they claimed was the first 3-D Orthopedic Software in the world, the PeekMed One.