Clinical data is required for all submissions of premarket approval and for more than 10% of 510(k) premarket notifications to FDA. A strategic combination of premarket and postmarket clinical studies proactively establishes a process to identify design problems and generate revenue sooner.
Design controls should be a device design process driver, not an afterthought. John Gagliardi, President of MidWest Process Innovation, shares how OEMs can treat design as a separate entity within a Quality Management System, the difference between user inputs and design inputs, and the business sense of good design controls.
The surgeon, OEM and supplier perspectives will come together to elaborate on the future of additive manufacturing during a special OMTEC closing session. Attend this panel discussion and networking reception to gain insight from 3D Systems, Arcam, Stryker, Zimmer Biomet and industry veterans Andy Christensen and P. James Burn.