For your scientific literature search, you can conduct scientific literature searches or reviews. If you are going to do those, then you need a good tool that will assist you in carrying out your scientific literature search. Good reporting, you must be able to report and report it effectively.
For a good tool to demonstrate that you’ve carried out your scientific literature search, at Celegence we’ve got a groundbreaking technology that we use at the moment called CAPTIS and that saves us up about 20% of our writer’s time. So you can get in touch with Celegence agents, for example, to demonstrate this new platform that we’ve got, and there’s a 30-day free trial. Go on to Celegence website, get in touch with us to arrange for a free demonstration. We will demonstrate how this new technology can save you time in carrying out a scientific literature review of your medical devices, irrespective of the therapeutic area.
For your reports, you have to make sure that you detail things properly under your scientific literature search review. The name of the device, the model, scope of the search that you are conducting, the period that you are covering, make it clear, the period that you’re covering, whether it’s 5 years, 6 years, 10 years, make sure you state those periods properly and clearly. The literature sources or the databases that you are using Google Scholar and the rest, make sure you state it clearly. The database search details, the search terms, the keywords that you are using, the selection criteria used to select and choose your articles, make sure you state those clearly. The output of your report, conclusions, suitability or how did you include certain articles? How did you exclude certain articles? the criteria and your search terms and everything, make sure everything is detailed properly in your report.
The notified body, when they’re looking at your scientific literature search report, they can say, yes, you’ve considered all the key words. The key terms you’ve looked into, you’ve used the right databases, your inclusion, exclusion criteria. Our platform CAPTIS will give you ways that you’ve never worked before. It can finalize reports that you can easily drop into your final word document or PDF straight away. It will format everything in a table for you. So it makes it easier when you’re using this.
You have to state clearly what the intended clinical benefit is. So what is the benefit to the user stated clearly? Identify the relevant GSPRs, at least GSPR 1- 9.4 if they are applicable for your particular device, make sure you state those and you state it clearly with clinical evidence. Clinical data that is relevant, and you have to make sure that it’s objectively right. Make sure there are no two ways about it. You have to make sure that you are demonstrating compliance to the GSPRs. So go through those and make sure that you’ve got the clinical data to demonstrate compliance.
Analyze ALL risks associated with the use of the device. So you have to make sure that all risk associated with the use of the device has been evaluated. Evaluate all your risk measures, make sure that you follow the ISO 14971 standard, the latest of it 2019. You make sure that all risks, harm parameters severity is recorded, controls before and after and analyze that risk. The final point to draw your benefit-risk ratio, use either qualitative or quantitative methods to demonstrate the benefit-risk ratio. If you’re using the scoring system, make it clear what your criteria is, how you are scoring, and then come up with scoring to prove that the benefit outweighs the risk. If you go in qualitatively, make sure that you say that clearly as well for the user.