Clinical Evaluation Repot Writer (CER Writer)
CER writer must be from the biology, or science field with experience in regulatory, development, usage on patients, or design technology. By way of an ever-increasing number of research studies, growing clinical experience, and new ideas and thoughts, new knowledge and information are constantly being added to the field of medicine.
All this scientific information needs to be effectively communicated with the target audiences such as physicians, the general public, healthcare professionals, and drug and medical device regulators. It involves various types of regulatory and research-related documents; disease or drug or device-related educational literature, contents of healthcare websites, healthcare magazines, and so on.
CER writers must require an understanding of medical concepts and terminology, knowledge of relevant guidelines, and good CER writing skills. Writer create documentation that regulatory agencies require in the approval process for devices, drugs, and biologics. Regulatory documents can be huge and include clinical study reports, clinical evaluation reports, and so on that a company gathers in the course of developing a medical device or a product.
We have qualified and experienced CER writers who can plan and execute a clinical evaluation, meeting the regulation and guidelines per the manufacturers’ requirements.
Essential Capabilities of a CER Writer
- CER writer will be capable of performing literature searches in various databases such as Cochrane, Pubmed, Medline, EMBASE etc. They know what exactly they are looking for, and they know where to search, planning a search strategy to bring up the most useful information.
- The individual writer must be able to effectively communicate scientific and regulatory information clearly and lucidly to the regulatory authorities.
- The person can perform the interpretation of data, do the clinical data appraisal and analysis of the data and present the results in tables, texts and graphs so that the target audiences understand what it means.
- CER writer will be an expert at giving truthful and complete information including negative findings, following copyright laws, not indulging in plagiarism, and so on.
- The person will be skilled at using software such as MS Word, referencing tools, drafting tools, analysis tools, and so on.
- CER writers can work across teams as well as independently.
- The individual will be good at time management and meeting deadlines and commitments.
Therefore, medical device MedDev 2.7/1 rev 4 or MDR article 61 CER writing is a combination of science and art that requires an understanding of regulatory aspects and keeping up to date with relevant guidelines, which is a must.
Why I3CGLOBAL for CER Writing?
Manufactures or CE Applicants usually connect with the I3CGLOBAL team for Medical Device Clinical Evaluation Report (CER) writing for several reasons:
- I3CGLOBAL offers customized solutions based on the risk class of the device and state-of-the-art features of the device considering the number of technical persons who have experience in regulatory documentation.
- Qualified and experienced clinical CER writers who can plan and execute a clinical evaluation, meeting the regulations and guidelines per the manufacturers’ requirements.
- Experienced in various software tools enabling unmistakable, organized, and efficient ways of documentation.
- Experts at literature search and appraisal, interpretation and analysis of data.
- Diligently work towards timely project completion.
- Provides well-structured procedures, SOPs, and associated templates.
- Guides and supports manufacturers on timely Clinical evaluation report updates.
- Provides truthful and complete information following copyright laws and without indulging in plagiarism.
We are a trusted partner for many manufacturers of Medical device CER writing, offering economic and timebound, MDR regulatory compliance solutions to achieve early CE Certification
I3CGLOBAL and their professionals are qualified and experienced to take any risk class MDR CER Writing projects from any part of the world.
Frequently Asked Questions
Knowledge of MEDDEV 2.7.1 Revision 4 is essential for a CER write?
Yes, knowledge of MEDDEV 2.7.1 latest revision is essential along with a good understanding of the MDR regulation, especially the role of the notified bodies in the review of a CER.
What are the two groups of CER writers?
- Medical writing companies OR Regulatory consultants like I3CGLOBAL
- Freelancers / Individual professionals
The I3CGLOBAL team typically have specialized qualified and experienced staff and can provide complete solutions for performing CER writing for any class of device at once. When you approach a company they have the necessary resources based on your risk class and state of the art
Freelancers or skilled individuals can be hired through public domain sites online or through other networks and social media. They are usually flexible in terms of what can be provided. The risk of appointing a single individual is a lack of communication as a team