If you have a business in the medical device industry, you know how challenging it can be to put any device on the market. Whether you are trying to launch a high-risk or low-risk product, you will have to go through rigorous procedures and adhere to strict regulations. Besides collecting all the relevant data about your device, you will need to notify the competent authorities and assure all the Notified Bodies about the safety of your product. This article will provide you with six tips for efficiently preparing a clinical evaluation report.
Start With General Information
The first thing the evaluators will look for when considering a new product is the general information about the device. Compile all the data about the device itself and its manufacturer in one document. Besides the intended use of the device, this document should also contain all the relevant clinical evaluations. You will need proof that your company is complying with the regulatory standards in your state. Be as concise as possible so the evaluators can check the info and move on quickly. If they can’t, your evaluation process might get stalled or your product rejected.
Identify The Requirements
For every country and state, there are regulatory laws concerning the market of medical devices. They describe all the tests and studies you will need to perform to complete an evaluation report successfully. Ensure you check what requirements you need to comply with well ahead of time to understand them. Pay particular attention to the safety requirements and all tests designed to ensure your device is safe to use. All your physical data, such as measurements or design produced when manufacturing and testing the device, will be required as well.
Search For Medical Literature
With medical devices that are considered high risk, you will need to submit relevant medical literature, whether it supports the need for your product or not. To include this in your clinical evaluation report, you will need to understand what publications are accepted as relevant. As evident at CiteMedical.com, there’s online help where they can review your data and provide you with all the necessary information for your submission. It will help you provide the highest quality product for those who rely on it daily, such as patients and medical professionals.
Compare Your Product
Comparing your device to a similar product that already went through the evaluation process and was approved, determines if your product will meet the requirements. This data will help the evaluation process go much faster, so you will want to make sure the product you use for comparison is as relevant as possible. The more similarities between the products, the more chances you have of getting approved. If there are any differences between your device and the one that’s already on the market, you must present those too.
Conduct Clinical Investigation
For some sensitive devices, medical literature won’t provide enough information. In that case, you will be required to conduct a clinical investigation before presenting your submission. If the medical equipment in question is sensitive or previously had a different use, a period of clinical testing will definitely be required. Since this will take a considerable amount of time, you will want to be informed about it as soon as possible. You will also need time to find ways and licensed medical professionals to test the device and will testify about it in your evaluation report.
Perform Post Market Surveillance
After your device gets approved and you launch it on the market successfully, you will still need to continue to compile information about it. This data will help you determine if the product performs as it should in the long term. It will also help you implement changes if needed or create a better product in the future. Your evaluation report should include all the steps you intend to make to track your product once it’s on the market. This information will indicate that you are ready to step in and make necessary changes if any problems occur.
Conducting a clinical evaluation report is a demanding process, but having all the relevant information will help you make it less time-consuming. However, you will still need to pay attention to the process to avoid any mistakes. Failing to do so will result in a loss of a substantial amount of money for your business, not to mention the hurt your reputation would suffer. Remember, if your team doesn’t have the expertise for it, you can always hire a professional to do the evaluation report for you.