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 announcement from the company. The system had already received CE mark approval.
PeekMed Pre-Op System Receives ISO Certification
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ISO 13485 is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It has recently 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 processes.
João Pedro Ribeiro, PeekMed’s CEO, said the CE mark approval and ISO certification achievements allows the company to provide surgeons with tools that assist them with “more rigorous and objective planning, making the surgery more predictable, effective, and safe for the patient.” The company develops, produces and markets medical software technology that provides more predictable patient treatments, currently focusing on orthopedic treatments.
In a 2016 press release, the company claimed that using PeekMed, a surgeon can reduce up to 20% of the surgery time and increase the accuracy of the team by analyzing the patient’s lesion in different angles. The hospital can reduce the sterilization costs in average 50% per surgery.
The current announcement said the company recently released an updated version of its system focused on a new design and new features. The innovative 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.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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