A medical device is a CE marked software or device whose product development process requires compliance with the ISO13485 quality system. A medical device can be hardware or software used to support the treatment of patients and treatment decisions, for example by using an algorithm or artificial intelligence.
Despite the name, medical devices are not always devices: they may also be software used to support patient care and treatment decisions, for example by using an algorithm or artificial intelligence. Medical devices are made to substitute the work of a nurse or physician and also to help patients or citizens find information and get self-care instructions online.
A medical device can be a symptom navigator that gives a citizen instructions on seeking medical attention, information about problems that can be treated at home or help in determining the cause of a problem. A physician can use the medical device to support the setting of a diagnosis or to help make treatment decisions.
In the future, there will most likely be medical devices available in the market for both patients and medical professionals to use for setting a diagnosis based on image analytics or to guide the care of a patient by personalizing it according to the patient’s needs.
One of the objectives is to reduce the work load of nurses. Chatbots or regularly sent patient surveys that allow the nurses to react if necessary and give instructions to the patient can help reach this goal. When a nurse does not have to be personally in touch with all patients, time and money can be saved.
The CE marking is used for the manufacturer to confirm that the device meets all relevant essential requirements.
The product manufacturer defines the requirements and risks, and the product is designed accordingly. Product quality and risk management are based on the manufacturer's expertise. The CE marking is a guarantee that the product has been manufactured in accordance with the standards set for medical devices.
The finished product is reported to the Valvira register.
The responsibility of the medical device manufacturer covers the entire life cycle of the product from its design to its withdrawal from the market.
There are many kinds of players on the market, which is why the regulations were tightened in May 2020. This guarantees only appropriate medical software products are available to citizens and health care professionals.
The ISO 13485 quality system applies to healthcare equipment, supplies and software. It can reduce risks and improve patient safety when developing healthcare devices.
The virtual team at HUS IT Management, a software product developer at Health Village, received the ISO 13485 certificate in summer 2018. The certificate applies to applications and systems utilizing algorithms, artificial intelligence, machine learning and data analytics in social and health care.
The certificate guarantees that HUS is committed to quality and that its quality system meets regulatory requirements. The certificate was issued by Inspecta Sertifiointi Oy.
Applications such as symptom navigators can also be called medical devices. The first CE marked medical device for HUS IT Management is the symptom navigator for acne on the open site of the Skin Disease Hub
The symptom navigator for acne makes a recommendation on whether or not the patient should see a physician because of their acne. It also provides instructions for the self-care of acne.
In the future, a person will be able to use Health Village services when trying to determine if they should go to the emergency clinic or when they have questions about autism.
Physicians, on the other hand, can use Health Village medical devices when assessing the probability of CRPS pain syndrome or lower back problems.
The quality and patient safety of the aforementioned and other Health Village applications and algorithms are guaranteed. This is indicated by the CE marking of the devices.