How to Develop Reliable Medical Devices

June 26, 2017

Innovative medical devices cannot only help to reduce operational costs, but they can also significantly improve patient outcomes.

It is therefore essential to develop the best possible device to maximize an organization’s cost while improving healthcare. For this reason, we are looking at how to develop reliable medical devices.

A Prototype

Every good medical device should start with a prototype. After all, you won’t know if your idea will work until you have tested it for yourself or within a medical setting. It’s during this stage that you can bring your idea to fruition, before identifying any potential flaws and embarking with further testing. For example, you may need to undertake additional EMC and safety testing. It’s important to consider all the big and small details prior to development. The earlier you identify any flaws, the quicker you can take the medical device to market. What’s more, it will also help you to create the best possible prototype for the healthcare industry’s needs.

Consult an Experienced Development Company

An experienced medical device development company will have the tools and experience to develop an idea on your behalf. For example, DeviceLab, an ISO-13485 certified medical device engineering company, has completed more than one hundred projects of varying complexities.

Quality & Safety Considerations

Before developing a medical device, it is vital to take the strict regulatory standards for both quality and patient safety into consideration. These standards have been mandated by the FDA and various agencies to ensure companies create safe and dependable products for both staff and patients. For instance, every US medical device company must comply with the FDA 21 CFR part 820 Quality Systems Regulations.

Risk Management

During medical device development, it is important to have a risk management plan in place to identify hazards, estimate and evaluate any risks and to develop, implement and monitor the effectiveness of each risk control measure.

Medical device regulators will deem risk management as a significant factor, so expect each company to establish risk management as part of a product’s lifecycle. This means you will need to create and store records and documents throughout the development process, which will demonstrate you have considered each risk and have taken the appropriate action. If the regulators can’t find records to prove a process happened, then the process didn’t happen, in their opinion. It is essential to keep records not only during the development stage, but throughout the existence of your company. For additional help, aim to align your company’s risk management process with ISO 14971.


There are many factors and considerations that must be made before you embark with any medical device development. You must develop a solid prototype, while paying close attention to any risks and quality issues along the way – while recording all your findings. However, a detailed idea and expert help can help you create a product that can transform the healthcare industry, while improving the lives of hundreds, thousands or millions of patients across the globe.


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