PeekMed, a 3D pre-operative system that helps orthopedic surgeons to plan their surgeries, has got the ISO 13485 certification and can now be used all over Europe.
The company announced today that it has achieved the ISO 13485 certification which is an important milestone for the company’s recognition in the market. PeekMed’s system has also the CE mark for its flagship product which allows it to be used all over Europe.
The CE mark allows PeekMed to be sold for clinical use in the European Economic Area (EEA) and Switzerland. The company is working on the FDA 510(k) approval for US market. PeekMed is used by more than 700 users worldwide.
“CE mark approval and ISO 13485 certification are an important achievement for PeekMed. This milestone validates the dedication of the entire team that works daily to deliver innovative products of the highest quality. This is to fulfill our mission and vision for the market, 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.” said João Pedro Ribeiro, CEO PeekMed.
PeekMed recently released an updated version of its system focused on a new design and brand new features. The innovative system, PeekMed v2.0, 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.
PeekMed, founded and headquartered in Braga, Portugal, is an innovative company with a highly focused and multidisciplinary team, working together to bring the best technology into the Healthcare industry. PeekMed develops, produces and markets medical software technology that provides more predictable patient treatments, currently focusing on orthopedic treatments.
BSI is the business standards company that helps organizations all over the world make excellence a habit. For more than a century they have been challenging mediocrity and complacency to help embed excellence into the way people and products work. That means showing businesses how to improve performance, reduce risk and achieve sustainable growth. As a global leader in helping organizations improve, their clients range from high profile brands to small, local companies in 182 countries worldwide.
João Pedro Ribeiro, CEO and Co-founder
Praça Conde Agrolongo, 123, 4700-312 Braga – Portugal
+351 935 147 151