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Quality And Usability Of Medical Devices

Oct 26th 2015 at 2:11 AM

The Food and Drug Administration of the USA was established to monitor the processes and products of the food and medical industry with respect to safety and quality. Food and medicine are the two things that humans need in order to lead a healthy life. Packaged food industry received a boost when corporate culture started to sow seeds in the lives of every second family around the globe. Quality of packaged food was something that could get ignored in order to cater to the increasing demand. The Food and Drugs administration took it unto themselves to release mandatory compliance standards that these industries needed to be in accordance with to get necessary clearances to run their industry.

Regular inspections with regard to REMS – the Risk Management and Mitigation Strategy – are made in these industries. Particularly in the case of pharmaceutical companies, these inspections are a serious matter, because in both literal and figurative terms, lives depend on them. The FDA REMS inspections are a test that need prior preparation for. While many drug companies are ready, many others find it difficult to align what they already have and what they need. Those that are unsure of the processes involved and the stakes, it is better for them to contact agencies that specialize in getting them prepared for such inspections.

In order to ensure safety in the industries of pharmaceuticals, the REMS testing programs have evolved over time to adopt to changing trends in medicine. This testing ensures that good quality drugs are circulated in the market and they are not sent into post production. There are specialized systems that gather information from manufacturing hubs that is then sent to the FDA. These are mostly web-based applications. Based on the analysis of this data, reports are generated and circulated.

Apart from this, there is also the usability testing of medical devices that a manufacturer must pass. This testing should be done early, and repeated often. It ensures that your device is user-friendly and delivers accurate data upon receiving input. Medical device usability testing ensures that the end-user understands the directions written on the drug packet or device that he would be using. Labelling comprehension is also an activity/test that ensures that proper instructions are communicated to the end-user. Both these aspects that go hand-in-hand, if taken care of properly, can make a device or drug efficient in terms of ergonomics, user-understanding and consumption/use. If there is a device that is to be used by a patient, then how effectively the patient understands the instruction manual and output results is what the company should work on. This information comprehension is what ultimately leads to usage patterns among patients. FDA human factors account for this.

Companies that provide consultancy regarding all the aspects above should be contacted as soon as possible after setting up a pharmaceutical company, because sooner or later you’ll have to face inspections. It is better to be prepared from the first step onwards. Visit to know more about FDA REMS.


James Williams is an expert when it comes to Risk Evaluation and Mitigation Strategies aka REMs in relation to the medical industry. He recommends as the name you should be trusting for any information related to medical device usability testing, FDA standards and more.

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