Medical Device Software & SaMDs – The Way Forward for Compliance

Our world is evolving in all life-related matters, and the field of medical sciences is one of them. Diseases that were considered deadly ages ago are not of even our major concern, thanks to all the advancements made in the previous years. The results of these advancements are vast, and many new ideas, items, gadgets, machines, and devices have been put into use, all of these help doctors, surgeons, and medical personnel to cater their patients in the best way possible. When it comes to medical devices, they are the tools that can be described as ‘any device intended to use for medical purposes’. The medical devices can range from a simple wooden tongue depressor to a complex scanning machine, medical devices come in a variety of different forms.

Since technology is advancing, new software is being developed that work as AI tools. Some prime examples of these tools are DreaMed Advisor Pro for patients suffering from diabetes, and Viz LVO for suspecting Large Vessel Occlusion strokes, etc. These software work in a programmed way. Viz LVO for instance can analyze CT scans by using AI and other algorithms to detect any LVO that can lead to stroke. The software then sends the information in the form of notification to the neurologists who can examine the information and can make decisions accordingly.

The future will surely see these software programs being used in replacement of the hand-held medical devices and putting them under the banner of rules, regulations, legislations and a common framework was necessary so that safe practice, safe innovation, and patients’ health can be ensured.

Different International Standards Required for Software Development

International organizations such as International Organization for Standardization (ISO), International Electrotechnical Commission (IEC), and the US Food and Drug Administration (FDA) have formulated some rules and regulations for these medical devices and SaMDs to follow.

ISO/IEC International Standards Relations on Medical Device Software and Software as the Medical Devices

ISO Standards for SaMDs

ISO 13485:  ISO 4385 provides a Quality Management System for the development of SaMDs.

ISO 14971: ISO 14971 provides guidelines for Quality Management System as well as risk management.

IEC Standards for SaMDs

IEC 62304: ISO 62304 along with ISO 62304 explains the processes of the software development cycle.

IEC 60601-1 and ISO 60601-2: Once the interaction of the software with the equipment is confirmed, the IEC 60601-2 and IEC 60601-2 highlight the safety requirements and other particular requirements related to the electrical equipment.

Altogether, these standards are essential for the development of a medical device software or development of Software as a Medical Device. It is necessary for the SaMDs and medical device software developers to get themselves familiar with the regulatory languages so that they can make the standardization process easier for them.

The IEC 62304 and FDA’s Level of Concern

The US FDA has enlisted three different levels of concern about the impacts which a medical device software or a SaMD can have on human health. The IEC 62304 has a classification model that is similar to that of the FDA’s level of concern. The IEC 62304 divides the medical device software and SaMDs into the following three classes:

  1. Class A
  2. Class B
  3. Class C
Class A, Class B & Class C Medical Device Software

The FDA according to its level of concern, divides the medical device software and SaMDs and their impact into three types which are as follows:

Class A

Medical device software or SaMD with a minor level of concern.

Impact on human life: No possibility of damage to health

Class B

Medical device software or SaMD with a moderate level of concern.

Impact on human life: Possibility of non-serious injury.

Class C

Medical device software or SaMD with a major level of concern.

Impact on human life: Possibility of death or serious injury.

Classification of SaMDs

SaMDs are classified upon the risk they possess. These SaMDs are classified on the levels of “inform”, “drive”, “diagnose” and “treat”. A device that is used only to inform the patient or medical personnel about a certain disease or condition is classified as “non-serious” while a SaMDs that is used for treatment is classified as “critical”.

Between the “non-serious” and “critical” categories, another category falls which is called “serious”. SaMDs can be classified under the non-serious category to serious up till the critical category upon the type of the function they serve i.e. either they inform, drive, diagnose or treat.

TS Q & E can help you in Medical Device Software Compliance

It is comprehensible that compliance for medical device software is not that easy and medical devices software development companies can face the challenge or difficulties in compliance of medical device software.

TS Q & E is a subject area specialist employing various engineers, and consultants internationally who are well aware of the medical device software process as well as the compliance related to it. You can contact us through TS Q&E Contact us form and let us know your requirements.

About the Author

Waqas Imam

S. M. Waqas Imam is associated with TS Quality as a Regional Partner. He is also an ambassador of Medical Device Community. He is an Industrial Engineer by qualification and served the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor of ISO 9001 and other management system standards. He had served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA. He also served as Expert Blog Writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.