If you’re in the medical field, you know how much detail goes into producing a new product especially, if you’re marketing in a highly-developed and progressive region like Europe. This line of work is even more challenging for budding businesses that don’t have the required experience nor the budgets to submit professional error-free data which is necessary to acquire certificates and licenses to conduct business.
The European Medical Device Regulation Certificate-EU MDR CER-for short is one of the most important documents medical devices’ manufacturers should acquire. This certificate is issued to ensure the compliance of new medical products with the set of regulations mandated by the European Union to manage the European marketplace. If you’ve attempted writing your own EU MDR certificate, you know that the real problem lies in conducting the Literature Search. This is the part where you search for verified articles and studies that can support your product’s claims. In order to help you out, here are 6 ways to improve your EUR MDR CER literature searches:
1. Use the Right Keywords
Just like you would in any other kind of search, identifying the appropriate keywords to retrieve relevant data will help you immensely in your efficient literature search. Think of the main purpose of your medical device, its main features and advantages, and then go about searching for publications and articles that you can benefit from. Try to be as specific as possible so you don’t waste time going through irrelevant information. Literature searches aren’t considered simple by any means. However, research has shown that the quality of literature searches done by the medical devices’ manufacturers themselves is often more meaningful and superior to those done externally. So, it’s definitely worth the try. Otherwise, if you don’t have the necessary capabilities in-house, the following suggestion might be more suitable.
2. Hire an Experienced Professional
Literature search is a complex task, the best way to guarantee that it is done impeccably is to seek guidance from experts or an authorized entity. Leave it in the hands of an expert who’s professionally trained to read between the lines and follow the recently updated EUR MDR to a Tee. In addition to the convenience and compliance benefits of hiring a professional, you’ll save your team a lot of hassle and time they would waste trying to find their ways around the literature search for your device. Unless they have prior experience or were directly involved in product development, it’s hard to imagine that they would have the essential skills to get it done.
3. Refine Your Search Strategies
Beyond finding the right keywords, it might be worth it to rethink and refine your search strategies. This is especially true if the topic of your search is considerably new and there still isn’t much data available online that you can refer to. Some of the methods that you can use to refine your search include the following:
- Filters: You can use filters to sift through the endless number of papers and studies on the topic you’re researching. You can filter by age group, sex or location.
- Boolean Operators: Named after the renowned mathematician George Boole, this method involves using a combination of ‘And’, ‘Or’, and ‘Not’ phrases to produce more focused results from your online search.
- Phrase Search: This method will allow you to do more efficient research as you’ll be able to add all the important information around your topic of interest.
4. Take Notes as You Research
Even if you’ll be delegating the literature search to a team of experts, you still have to be involved in the process as the business owner. While you’re at it, always remember to take notes of information shared while the writing is underway. Not only will this give you a bigger chance of challenging the data to dig even deeper for better results, but you’ll also get the chance to ensure the logical structure of the literature search and adjust where necessary.
5. Don’t Ignore Older Publications
In your attempt to keep your search up-to-date, you might be tempted to ignore the older publications. However, if you want to improve your literature search, you have to go through the older publications just as meticulously as you would the recent ones. Reading through the progression of the scientific studies over time, you’ll gain a deeper insight into your topic and can enrich your search with valuable additions.
6. Be Critical when Reviewing Your Search
The last stage before submitting your literature search is by far the most important. Go over the search multiple times and be critical to pinpoint any deviations from your intended study. Furthermore, you should consider collecting feedback from experienced reviewers as this will give you the chance to go over your work and make the needed amendments.
Perfecting your literature search will give you a headstart on your application for the EUR MDR CER. With the new regulations, you’ll need the extra hand to limit your potential losses resulting from late submission. The above tips will help you improve your literature search to acquire your EUR MDR CER and start doing business.