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Medical Device and the Need for Security


Security of Medical Devices is a hot topic for healthcare IoMT (‘Internet of Medical Things’) as new developments have kept accountability and responsibility in a grey area. The most common issue exposing devices to threat is a lack of information about devices connected to the network.


Network administrators have very little idea about who has access to what machines and if the information stored on the system is safe or not. This raises a big concern about cybersecurity. Similarly, innovators are unaware of different regulations in different countries. For example, the European continent has 3 or more, different legal requirements for medical device manufacturers to fulfil.  In these times, a Manufacturer must create a device that is safe from all known vulnerabilities and is well prepared for unforeseen contingencies.


Our experts believe that Manufacturers should try to gather as much information as possible from the device ecosystem. This information will help manufacturers to assess the vulnerabilities and the risk. Once the entire data is accessible, an organisation can mitigate some technical, clinical, or regulatory risks. No tool can make a device 100% secure. It is the practices and ethics followed by all ecosystem members who help provide complete protection and security to the patient and the medical device.


At times, any tool or checklist can pose a severe threat to the medical device because a manufacturer can get a false sense of security by ticking off the pointers. A toolkit or checklist used for one device might not be a suitable solution for another device. Manufacturers need to ensure that they take complete control of safety concerns and seek expert help wherever needed.


A holistic approach might be a possible solution to fix all vulnerabilities for a short period. Companies and Manufacturers should ensure that their medical device ecosystem is overhauled regularly and all factors are taken into consideration. It is often seen that manufacturers put less importance on certain critical risk categories, which includes:



These categories have proved to be essential areas of focus during the manufacturing process. Without clinical trials, a product cannot be placed on the market, so performing a clinical checklist can eliminate clinical risk, but then Regulatory Requirements come into the picture. To commercialise any medical device and launch it into different countries, one has to do a thorough check for regulatory compliance. If you ignore the regulatory requirements, your device might be called back from the market, leading to financial and organisational risk.


Therefore, manufacturers need to focus on 360° protection and safety. The end goal in safety and security is not to be risk-free but to be resilient and risk-averse.


Organisations must be prepared, and they must validate controls, the people and processes the organisation runs on and then rehearse for disaster—that includes preparing and rehearsing for the "bad event."


Why let your innovation be affected and exposed to these multiple risks? Protect your device with constant and holistic Regulatory support from our Experts at Med-Di-Dia

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