Medical Industry and Device Standards

The importance of medical device Standards

In the medical industry, requirements for goods and services change depending on the device, the materials needed, the intended use of the device, the country of manufacture and much more. Meeting industry and international Standards means a manufacturer is reaching the required benchmarks for safety, quality and performance. 

There's no room within the medical device industry to not meet these set benchmarks. The safety and wellbeing of patients depend on the device being reliable to consistently meet their needs. Standards also assist organisations to demonstrate compliance requirements are met. With complicated and ever-changing compliance needs in the medical device industry, every organisation must be agile in this environment. The ability to change processes or procedures to ensure these requirements are met are essential. 

Medical device quality management systems & ISO 13485 

A quality management system (QMS) includes the business processes that work towards meeting customer requirements and continually improve overall satisfaction. A comprehensive approach to quality management combines the need to align business processes, leadership, employees and more to ensure a high-quality result for goods and services.  

ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes is the international Standard that provides requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It supports manufacturers in designing systems, as well as providing direction on how to maintain the effectiveness and safety of their processes and products.

Using a Standard like ISO 13485 increases a device's effectiveness, safety and consistency, making it a valuable contribution to the public's health. Learn more about quality management systems in medical devices with ISO 13485. 

Medical device risk management systems & ISO 14971 

A risk management system helps to identify risks and sets processes in place to manage each identified risk appropriately. ISO 14971 Medical devices - Application of risk management to medical devices is the international Standard that specifies terminology, principles and processes to manage risks in medical devices. This Standard provides a thorough process for manufacturers within the industry to assess, monitor, and control risks in the creation and use of a medical device. 

To find out more about the newest edition of this Standard, read our article 'Understanding the revised risk management Standard ISO 14971 for medical devices'. 

Medical device labelling & packaging Standards 

Medical device labelling and packaging play an important role in the use of the product. Labelling requirements are essential to meet regulatory and compliance obligations and assist with the safe use of the device.  

They provide instructions on general, safety and product information. This includes information of the manufacturer, warnings, handling and storage instructions, operating instructions and more.  

Important international Standards include the two parts of ISO 15223 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied. Learn more about medical device labelling and how requirements differ across the globe. 

Medical device safety Standards 

Depending on the application for the device, specific Standards have been developed to provide guidance to ensure safety benchmarks are met. Both the risk management and quality management Standards developed specifically for medical devices provides a great foundation to take appropriate steps to prioritise safety.  

There are then groups of Standards organisations can implement depending on the device. The IEC 62304 Medical device software - Software life cycle processes Standard is applicable to a medical device with software. If the medical device is electronic, the IEC 60601-1 Medical electrical equipment - General requirements for basic safety and essential performance series of Standards is applicable. 

ISO 16142 Medical devices - Recognized essential principles of safety and performance of medical devices is split into two parts. Part 1 (ISO 16142-1) relates to the general essential principles and specific essential principles for all non-IVC medical devices (in vitro diagnostic). Part 2 (ISO 16142-2) relates to general essential principles and specific principles for all IVD medical devices. Both also provide guidance on the selection of other important Standards. 

The ISO 10993 Biological evaluation of medical devices series of Standards have been developed for devices that come into direct and indirect contact with the human body.  

Medical device sterilisation Standards 

Sterilisation Standards play an important role in the safety and useability of a medical device. Whether a device requires sterilising for single use or to be reused, there are certain methods required for specific products. 

The international series of Standard ISO 11137 Sterilization of health care products - Radiation provides guidance on sterilising medical products. This series includes information for radiation requirements for development, validation and routine control of sterilisation processes and guidance on dosimetric aspects and more. 


Standards are vital in guiding medical device manufacturers, distributors and healthcare providers on how to identify and prevent risks, ensure high-quality devices are made and feel confident they have met their essential safety and testing requirements.