PeekMed obtains quality assurance certification for medical devices

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.

About PeekMed

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.

About BSI

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.

Contact

João Pedro Ribeiro, CEO and Co-founder
Praça Conde Agrolongo, 123, 4700-312 Braga – Portugal
+351 935 147 151
info@peekmed.com
www.peekmed.com

About Peter Coffaro 1134 Articles

A growth-driven and strategic executive, Peter Coffaro commands more than 20 years of progressive management success within the medical device industry. As a District Sales Manager for Stryker Orthopaedics, Peter was responsible for managing and directing a regional sales force to achieve sales and profit goals within the Rocky Mountain region. Previously, he was the Director of Sales & Marketing for Amp Orthopedics. In this role, Peter was responsible for planning, developing, and leading all sales and marketing initiatives. Peter is a former orthopedic distributor in the Pacific Northwest. He has also worked with DePuy Orthopaedics as well as Zimmer, and held positions in sales, sales training, and sales management. Peter has an extensive background in organizational development, business development, sales management, negotiating and P&L management. Peter holds a B.S. degree in Biology from Northern Illinois University.

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