Requirements management tool for medical devices

A company involved in the manufacturing and design of medical devices has to spend a lot of time on research in design and development. Companies spend millions of dollars and manpower just to design the framework of the manufacturing process and making guidelines for the safety of the device.

What is the need for a requirement management tool?

If the fault or an error is found in the device it can lead to a recall of the device. This will hamper the reputation of the company manufacturing the device. The sale of its medical equipment may fall and clients may retract their orders.

If the lives of the patient are at stake due to any technical glitch then the situation is even worse. This could also lead to fines by regulating bodies and your company may even lose license for manufacturing medical devices.

How can a requirement management tool help the manufacturing industries?

The use of a requirement management tool is to help the device manufacturing and designing team in three parameters.

Finding our the requirement of a medical device

This is important to start the design process. A medical device should be manufactured to help surgical and operating procedures and save lives. This is done to ease the workload of the medical personnel as well.

Mitigate risk

It is done to mitigate risk especially the mishaps and unfortunate events. If the lives of patients are compromised due to faulty equipment then you have to face lawsuits in the court rater than designing medical devices.

Do case-wise testing

The testing phase will enable the experts to find out all the cases and possibilities while doing the testing. Emphasis is given to all the operating procedures of the equipment based on certain conditions.   

What are the things that you have to consider choosing a best requirement management tools?

Finding out traceability

Traceability is a term that increases the efficiency, and risk in designing and manufacturing procedures. It is an important parameter that helps you to focus on the functionalities of your medical device.

Will the tool help you to identify the risks

Risk management is very important both in the design process and when it is being used in medical institutions such as hospitals and pathology centers. It helps you to find out the design flaws or loopholes in the device that may cause an accident.

Ease of use

It is very important to look at how easy it is to use your requirements management tools. As it will be used by the design and development tool you have to ensure that all your staff knows how to use the tool to adopt safer practices.

Are you searching for the right tool? Then visit Orcanos website because they have the right tool for all types of medical devices manufacturing industries. For more information about please, visit


Requirements Management Software


Orcanos provides an cloud ALM system that combines quality (QMS) and regulations into the R&D process, thus assuring better FDA, ISO, CE compliance.

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