Having a great medical software product is one of the most important agenda points in many healthcare entities and organizations. However, it is not enough to present the particular solution in the wider market that requires the providers to be compliant to the specific standards.
Most of the time, it is something that both the project owners and developers will need to consider during the software development stages. The compliance status to a specific set of standards can be one of the factors that can slow down the development stages.
It is also possible for the project medical software development owners to trace back and do the same work again and again. The double-checking is often done in the software development cycle to make sure that the software is being compliant to the particular standards. When it comes to medical software, the developers will need to stay updated to the regulations and laws in local and international domains.
“Medical device software rules” related to norms and standards developed by healthcare market authorities to ensure the safety of the device or software under consideration. Because of security and safety issues, it is becoming increasingly important to monitor and regulate the expansion of the medical Internet of Things (IoT).
Rules and regulatory organizations vary per market, but we will examine many commonly recognized principles in this article. Consider why sticking to their standards is so important to a software developer in the following paragraphs.
FDA’s device software functions and mobile medical apps policy
In order to reach the medical market, your proposal must typically fulfil a number of requirements. Medical device software is controlled under the jurisdiction of medical device regulation, and it all relies on the medical device class in terms of potential patient harm. This category includes the following items.
If your specific project is focused on the EU market, it is appropriate to use the software development approach that is compliant to the regulations in the regions. In this case, you can follow the EU Medical Device Regulation for the EU Market.
If the particular project is only for the US market, then the project owners will need to maintain compliance with the FDA regulation.
There have been many health organizations that have been spreading their services across the globe. When one needs to develop a particular software for the global market, it is important to develop software that is compliant with the ISO IEC 62304 regulation.
When it comes to the FDA Regulations, there are three types of software categorized in healthcare:
SaMD – Software as Medical Device
SiMD – Software in a Medical Device
Software in the manufacture or maintenance of medical devices.
The regulation appointed to your software project will depend on which category that it lands.
Consider checking on the official site of the FDA to find out more about the particular information.
You might also want to check on the official site of EU Medical Device Regulation if your software is targeted to the EU market. Or, consider comprehending the ISO IEC 62304 for the standard used in the international domain.
The regulation issued by the FDA, EU MDR, and IEC 62304 is needed to make sure that the development process will be conducted according to the requirements. Therefore, the actual hope is to make sure that the final product will comply with all the standards.
The software compliance to the regulations will also bring significant benefits for the project owners or the healthcare entities who use the software:
l The essential assumption of healthcare software is that no harm should be done to patients’ health or safety, and this idea applies equally to medical Internet of Things solutions.
l Throughout the development process, the patient’s safety and privacy should be your primary priority.
l The standards for medical device compliance and software requirements ensure that your solution will not endanger the patient’s safety or well-being.
l Assuming your IoT is safe for patients, the regulatory authorities in the market where you plan to sell it will likely give their approvals confirmation.
l Any regulatory authority’s primary focus is on safety and quality, regardless of the market.
The FDA recognizes that software applications (apps) and mobile applications (apps) have a wide range of present and prospective functions, as well as potential benefits and risks to public health.
As a result, the FDA is releasing this document to inform manufacturers, distributors, and other organizations about how it intends to exercise its regulatory jurisdiction over software programs designed for use on mobile platforms (sometimes known as “mobile apps”) or general-purpose computer systems.
Because mobile and other general-purpose computing platforms are quickly increasing and becoming more capable of deploying software functions, the Food and Drug Administration (FDA) is issuing this advice paper to clarify which subset of software functions it wishes to apply its authority to.
The FDA refers to device-software functions as “device software functions.”
“Software as a Medical Device (SaMD)” and “Software in a Medical Device (SiMD)” are examples of this.
Software as a Medical Device
In a new guideline paper, the Food and Drug Administration (FDA) provides information on the software functionalities of mobile medical devices and mobile medical applications. Although the most recent version of the policy was released in September 2019, no new regulations or criteria were included. Additionally, the report makes a number of non-binding suggestions and clarifies a number of issues in this regard.
Class IIa medical device
Class IIa implantable devices have a lifetime in the human body of between 60 minutes and 30 days. Medical goods include hearing aids, blood transfusion tubes, and catheters. Class IIa medical devices do not require any chemical activity with or on the body to achieve their intended effect.
Medical device software development
It is important to work with an experienced and credible partner to attain particular goals. In this case, Galaxy GW can be the most potential partner that you want to work with.
Galaxy GW comprehends the regulatory requirements of the market wherein you want to design the software. The professionals know the importance of medical device software compliance. For healthcare providers, compliance is one of the success keys to thriving in the industry.
Besides staying competitive in the market, it will also provide long-term benefits for their patients.