Writing a clinical evaluation report is as complicated as it is important. A clinical evaluation report is a formal and technical document essential for any medical device if the device has to be sold in the European and ASEAN nations.
Therefore, an effective Clinical Evaluation Report (CER) plays an important role in the commercial success of your medical device. However, preparing a CER is not an elementary task; it is not something you can wrap up once and for all and never go back to it. Writing a CER is an ongoing process and the document has to be constantly revised and updated. Furthermore, it is a document that has to be prepared with a lot of focus and deliberation.
The process of writing a CER requires the writer to not only be adept at writing, but also possess a good understanding of scientific, medical, and technical aspects. Given the skills required, it is hard to come across writers that fit the bill. However, if you know what to look for, the process of selecting a CER writer becomes simpler. Here are a few points that will help you choose the ideal clinical evaluation report writer.
Sound Technical and Clinical Acumen
While preparing a CER, the writer has to review numerous scientific literature containing studies related to medical equipment. In addition, the prepared CER must be reviewed and updated repeatedly, based on observations, feedback, and clinical and experimental testing of the device. The writer will not only have to analyze this data but will also have to interact with numerous dynamic and multi-functional teams and also act as a liaison between them. To accomplish all this, the writer must have a strong technical understanding and clinical acumen. The writer should also be comfortable with searching for and understanding technical papers and peer-reviewed articles. A class 3 CER relies heavily on clinical data; therefore, clinical acumen also becomes important.
Writing experience is naturally the first thing anyone looks at when hiring a writer. But when hiring a CER writer there is a specific writing experience that is desired. The writer must be experienced in writing CERs, and, if not CERs, at the very least, scientific, medical, and technical content. Relevant writing experience is one attribute that is commonly found in medical freelance writers due to the wide variety of writing projects they tend to undertake. Furthermore, freelancers that specialize in CERs also tend to be familiar with Medical Devices Documents (MEDDEV). While many writers have a lot of experience writing clinical trial documents and clinical study reports, that experience is not very relevant. The first-hand experience of writing CERs and MEDDEV is extremely important and this is where freelance writers hold an edge.
Familiarity With Regulations
If preparing a clinical evaluation report for the European market, or even other markets, the writer must be well versed with regulations and the regulatory bodies. CERs must be prepared in accordance with the regulations, and possessing ample knowledge of the relevant regulations is imperative for a CER writer. The CER writer you choose must have strong knowledge of MEDDEV, which is a 5 stage clinical evaluation protocol required by the European Union. The five stages include the scope of the new CER, collection of relevant documents and literature reviews, processing and analysis of the collected documents and data, analyzing the competitors, and updating the CER with Post Market Surveillance (PMS) and Post Market Clinical Follow Up Data.
Knowledge Of The Device
One of the most attractive skills of a CER writer is their ability to understand the inner workings of devices and analyze and process quality control data. Unfortunately, the majority of medical writers have little to no knowledge of the medical devices they are writing about, although some tend to have some knowledge regarding devices that they have previously written about. A writer that is well versed in the operation and the working principle of the device will write a good CER.
Writing a CER is a complicated task and there are various skills the writer must possess to successfully write one. Not only should the writer possess a knack for medical technology and comprehend scientific research papers and clinical trial results, but the writer must also be familiar with the regulations these reports are built around. These skills are generally developed over time as the writer undertakes more and more projects and gains experience. Focusing on these skills while looking for a writer will help you narrow down to one that fits your needs.