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ROI CalculatorThe field of Software as a Medical Device (SaMD) is a developing sub-sector of the medical device industry right now and many companies with software production capabilities are expanding into medical devices manufacturing. However, even if a company is into SaMD, the manufacturer has to comply with a number of regulations, especially regarding their quality management systems (QMS).
The International Medical Device Regulators Forum (IMDRF) emphasizes that SaMD refers to software that is meant for specific medical applications and is capable of executing its functions independently of any medical device.
According to IMDRF regulations, the manufacturers of SaMD need to set up a system of governance, leadership, and accountability that will guarantee the safety and efficacy of SaMD. SaMD's management has to ensure that there is enough governance and leadership throughout the SaMD process, namely "defining the strategic direction responsibility, authority, and communication to assure the safe and effective performance of the SaMD."
The QMS and quality policies and objectives are developed by the leadership of the company. Moreover, the leadership plays a key role in providing the structure and support to put the processes in place and to ensure that quality policies and objectives are followed. Furthermore, the leaders assume the task of verifying the efficiency of what they have put in place. So the verification may include internal audits and management reviews of the QMS.
To sum up, the management of a company is charged with ensuring proper resources for the effective development of SaMD. They must employ the right people and utilize the tools, data, and communication channels to satisfy the needs of regulators and customers alike.
SaMD developers have to steer through the following unique set of challenges:
Cybersecurity Risks: 89% of healthcare organizations experience one or more cyberattacks every week, accumulating more than 43 breaches yearly and threatening the integrity of devices and the security of patient information.
Rapid Development Cycles: Continuous deployment frameworks enable innovative breakthroughs but these methods also deter classical validation because of delays in approval.
Validation Pitfalls: Manual tracking of changes and inconsistent testing can lead to mistakes, and the fact that validation planning is suboptimal makes it possible for up to 30% of Software as a Medical Device projects to be delayed.
Interoperability & Data Integrity: Although the importance of seamless interaction with the EHRs, imaging systems, and wearable devices cannot be underestimated, the various inconsistent regulations prevent data information from being exchanged easily.
According to the recommendations of IMDRF, SaMD QMS should include: “A set of SaMD lifecycle support processes that are scalable based on the size of the company and applied uniformly throughout all the procedures of realization and usage.” According to the written recommendations, the basic processes include product planning, risk management, document and record control, configuration and management control, and measurement, analysis, and improvement of processes and products.
SaMD realization
According to IMDRF's third quality management principle for SaMD, there must be “a set of realization and usage processes that are suitable for both the SaMD distinction and the organization size, which includes the essential components needed to ensure the safety, efficiency, and functioning of SaMD. There are key lifecycle processes that should be identified in the methodologies used by SaMD manufacturers.
