A clinical evaluation report is needed for all medical devices to ascertain that they have complied with the laid regulation before being supplied. The report is a technical document that provides an overview of the medical device’s composition and design, application and intended usage, literature reviews, clinical trials and outcomes, instructions for use, and protocols. It is best to get a clinical evaluation report writer with the relevant experience considering its weight in determining whether the regulatory board will approve the product. The following are factors that you should consider when selecting the CER writer.
Effective Industry Insider
The CER writer should have a commendable background in Clinical Methodology in all the industry’s therapeutical areas. The expertise is necessary because CER writers represent their companies at the Regulatory and Compliance conferences and global meetings that discuss how regulations affect the medical device’s safety.
The writer should also have a good reputation and excellent communication skills because of the frequent presentations that have to be presented to different regulatory bodies. The CER’s expertise will determine how successful the manufacturer’s devices will sail through the markets because they need to follow all the stages stipulated in the EU guidelines.
Experience of the CER Writer
The EU regulations have changed over time, and the best writer should be aware of the improvements made in the reporting guidelines. Some of the changes include post-market surveillance documents and clinical investigation analysis. The CER writer should also have an in-depth knowledge of medical device manufacturing, quality control data, and internal safety assessments. The EU revised its regulations in 2017, and they published new rules that should be followed by the CER writer. Getting an experienced CER writer will give you the opportunity of having seamless processing and delivery of the document for a quick approval.
Scientific Literature Knowledge
The literature protocols followed by the EU CER writers include objectives, systematic search, outcome, control and intervention queries, patient characteristics, and non-biasness. Therefore, the writer should master analytical skills, meta-analysis, literature searches, and collection of clinical evidence to excel in this field. The CERs writers should also do peer-review and clinical research to prove that the device is fit for use even after they have been released in the market. It is also crucial to check whether the writer is conversant with index Medicus, MEDLINE, Cochrane Database of systematic reviews, and Excerpta Medica to produce a high-quality report.