QA Standards for Medical Devices

Across industries, standards are an important way to safeguard product conformity while simultaneously harmonizing requirements both nationally and internationally. Quality assurance is vital to ensure that the producer correctly applies standards.

Usability is a key component of safety for medical device usage, and a clear and understandable user interface is vital. The standard which covers this is IEC 62366.

The Quality Management System is the backbone on which the development of safe medical devices is built. The standard which covers this is ISO 13485.

ISO standard ISO 14971 is used for the application of risk management to medical devices. This standard was developed specifically for manufacturers of medical devices on the basis of established principles of risk management that have evolved over many years.

Across industries, standards are an important way to safeguard product conformity while simultaneously harmonizing requirements both nationally and internationally. Quality assurance is vital to ensure that the producer correctly applies standards.