What is the International Standard Used for the Medical Software Development Process?

The future health software for medical devices has been a popular topic to discuss when in many relevant events. Some experts have noted the importance of the latest technology in the software industry that can help improve healthcare services, which in turn saved many lives across the globe.

You can be one of the folks who have been in the bubble of medical software safety.

Each healthcare must be able to allocate resources for their services. One of their milestones is to get the latest technology in the software industry so that they can maintain their great service. If you are planning to develop a specific medical software, there are few things to consider first before proceeding.

It is imperative to take a holistic approach in order to design the most appropriate solution for the problem. There are some variables to evaluate before continuing with the project such as human factors, QA, validation, assessments of risk, mitigating the risks, market access, as well as the programme of the bodies.

It is also important to understand that the software itself is not a standalone, but as an integral component of delivering the particular healthcare services.

Healthcare software importance

Healthcare software is still a broad term to comprehend. But in essence, it is the main category of the software that is used for delivering healthcare services to the patients. The software is strongly linked to a wide array of healthcare technologies such as record systems, smart devices, and so on.

The main purpose of healthcare software is to serve the patients for the better and help them to reach a high level of wellness. That’s why it is sensible that healthcare services always look at the latest technology in the software industry in any way they can.

Health information technology enhances treatment quality, promotes patient safety, reduces medical mistakes, and facilitates patient-provider communication.

There is a demand for reliable and affordable medical recording software in low- and middle-income nations. The OpenMRS community, for instance, helps to meet this specific need by building and maintaining an open-source electronic health record (EHR) system that is optimized for low-resource environments and is totally free.

Health information technology benefits medical clinics by improving patient data accuracy and allowing physicians to understand a patient’s medical history. This improves patient care overall.

The medical history helps doctors treat patients better and prevents overprescription of life-threatening drugs. In some cases, patients could possibly hide the facts in their medical records. The doctors and health practitioners can help them by unveiling the real records. They will use the holistic approach to provide better services tailored specifically for the patients.

Without medical records, doctors would have to rely on patients’ memories, which might lead to inaccurate medical histories due to forgetfulness, complicated medication names, or diseases impacting memory recall. In many healthcare services, a doctor can handle hundreds of patients. Relying on memories alone won’t be sufficient to provide the best services to their patients.

Patients with illnesses and problems are rapidly benefiting from health information technology.

Patient care improves security, effectiveness, patient attention, communication, education, timely service delivery, efficiency, and fairness in healthcare.

Custom software implementation

Many healthcare entities and organizations have turned their interests to the advantages offered by the custom of future health software production. On many occasions, the generic healthcare solution cannot offer many perks in managing and delivering the tailored services for the patients. As we know, there are many formats and alternatives of the entities such as hospitals, clinics, mobile clinics, rehab centres, nursing homes, and many more. Each of them needs customized software that can cater for their needs and requirements.

Telemedicine

Telemedicine applications have made such significant changes in the patient’s treatment. Thanks to the advanced telemedicine software, the patients won’t need to stand in the lines or come to the clinic physically to consult with their doctor. Each individual has an equal opportunity to use the online treatment.

Cloud Solutions

Healthcare cloud solutions can make cloud services available to any type of medical organization. In this case, Glorium Tech will help the clients to solve the particular problems that their clients have. They will use cloud-based custom medical services.

IEC 62304

In the international corridors, it is important to be compliant to IEC 62304 when developing medical software safety.

It is an international set of standards that is the product of IEC – International Electrotechnical Commission.

Basically, these standards set conducts the supervision and specifications of the medical software life-cycle progress for the particular software creations.

On an international scale, the developers who are planning on specific medical software development projects can use this standard if the solutions are targeting the European Union, the US, or the other countries that are significant to the latter standard.

The International Electrotechnical Commission (IEC) 62304 standard, according to the International Electrotechnical Commission (IEC), provides a set of processes, activities, and tasks that are intended to create a common framework to facilitate the development of safe and tested software for medical devices.

The standard defines three levels of security, each of which is decided by the potential consequences of software failures for patients.

  • Class A: No injury or damage to health is possible
  • Class B: Non-serious injury is possible
  • Class C: Death or serious injury is possible

The standard will make sure that the particular software will be correctly verified before injecting the solution into the medical device. There will be the responsibility of the developers to make accurate software documentations which are compliant with the standard.

In a nutshell, IEC 62304 establishes recommendations for recognizing potential hazards linked with medical software errors or bugs and describe how the risk level associated with a medical device should be properly evaluated.

IEC 62304, once the device risk level has been defined, sets forth all risk management procedures required during the life of the device.

Under the specifications, the medical device is loosely described in comparison with the description in the Medical Device Regulation.

There have been debates about the boundaries of the framework.

For instance, when an operator runs a medical device software on his PC, will his PC become a medical device?

There might be a lot of questions and topics that you need to discuss with your developer’s team. Therefore, you can’t go wrong consulting the Glorium Tech professionals regarding this matter.