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Ward Callens

Director of Quality Management, Risk & Compliance, Materialise

Ward Callens obtained a master’s degree in law from KU Leuven (1998) and an MBA from Vlerick Business School (2008). After having started his career in regulatory affairs roles in the telecommunications sector, he joined Materialise in 2008 and has served in a number of management functions. Since 2015, he heads the Materialise corporate quality and regulatory affairs department.

About Materialise:
Materialise incorporates 30 years of 3D printing experience into a range of software solutions and 3D printing services, which together form the backbone of the 3D printing industry. Materialise’s open and flexible solutions enable players in a wide variety of industries, including healthcare, automotive, aerospace, art and design, and consumer goods, to build innovative 3D printing applications that aim to make the world a better and healthier place. Headquartered in Belgium, with branches worldwide, Materialise combines the largest group of software developers in the industry with one of the largest 3D printing facilities in the world.

Materialise Medical, which has pioneered many of the leading medical applications of 3D printing, enables researchers, engineers and clinicians to revolutionize innovative patient-specific treatment. Materialise Medical’s open and flexible platform of software and services, Materialise Mimics, form the foundation of certified Medical 3D Printing, in clinical as well as research environments, offering virtual planning software tools, 3D-printed anatomical models, and patient-specific surgical guides and implants.


Session:

Software as Medical Device

Location Einstein A Room Start / end time 4:00 pm to 4:45 pm

Nowadays, a stand-alone software being a mobile or web application can qualify as a medical device. This workshop will focus on the specificities of such products and the regulatory pathway to be CE marked and FDA cleared.

Through concrete cases, Software Medical Devices manufacturers will share their experience and lessons learned.