1. Scope

Keywords

Rationale

Currently, there is no defined framework or guidance pertaining to additively manufactured medical devices at the point of care. As such, this standard will bridge any gaps in good manufacturing practices that are applicable to the production of additively manufactured medical devices at the point of care. Additionally, there exists no standard definition on additively manufactured devices at the point of care. This standard will also fill this gap to facilitate ease of understanding and adoption at the manufacturer and regulatory body level.