The introduction of a quality management system is mandatory for manufacturers of Class IIa, IIb and III devices. Whether you are one person manufacturing your device in your garage, or a well-established manufacturing facility with hundreds of employees, quality should be your number one priority.

Standards are established by several national and international organizations. Some of the most well known include the International Organization for Standardization (ISO), American Standards for Testing of Materials and European Committee for Standardization (CEN).

Standards can be described as vertical or horizontal, depending on how broad they are. A vertical standard is specific to a device, and a horizontal standard applies to a wide range of devices.

For example, the following four standards are most frequently applied to medical device companies:

ISO 13485 - QUALITY SYSTEM

Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

ISO 14971 - RISK MANAGEMENT

Specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

IEC 60601-1 - ELECTRIC SAFETY

Contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard.

EN 980 - USE OF SYMBOLS ON LABELING

Specifies graphical symbols for use in the information supplied by the manufacturer with medical devices (including in vitro diagnostic medical devices). This standard aims to reduce the need for multiple translations of words into national languages, simplify labelling wherever possible, prevent separate development of different symbols to convey the same information and align the presentation of information required by all EEC Directives on medical devices.