Medical device design validation is a component of design controls that (in part) demonstrates the safety and efficacy of the medical devices to meet User Requirements. Design controls are part of a larger quality system, and were introduced into the FDA’s Quality System Regulation (QSR) in 1996 and implemented in 1997.
Per 21 CFR Part §820.30, medical device companies “shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.”
Though design controls are defined by the FDA, similar assurances are required by regulatory bodies in Europe, Canada, and elsewhere — though differences exist among these requirements.
When should you establish design controls?
Manufacturers should establish design controls when they have the intent to produce a medical device.
A key component of design control is traceability, specifically outlining how each stage in the design process (e.g., user needs, design input, design process, design output, and final product) relates to and informs one another.
QA Consulting is an expert in helping medical device manufacturers establish design controls. Through our years of experience, we’ve identified common pitfalls and ways to overcome them.