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About a CER Writer
CER writer plays a crucial role in the medical device clinical evaluation. Clinical Evaluation Report CER Writer must be from a biology, or science background with experience in European medical device regulation with skill in easily understanding medical devices state of the art, usage by patients, and technology.
A capable CER writer is knowledgeable about a variety of regulatory and research documents, disease conditions, device-related educational materials, healthcare website content, and healthcare publications.
CER writers must require an understanding of medical concepts and terminology, knowledge of relevant guidelines, and good CER writing skills in addition to the above skills. CER writers create documentation that will be reviewed by a panel of notified body reviewers before the approval process for devices. 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.
Diverse set of Skills and Capabilities for a Medical Device CER Writer
The below capabilities ensure that the CER writer can produce a thorough and compliant report that supports the safety and efficacy of medical devices
- Clinical Evaluation Report 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.
We have qualified and experienced CER writers who can plan and execute a clinical evaluation, meeting the regulation and guidelines per the manufacturers’ requirements.
Outsource CER Writing to I3CGLOBAL and Benefit from the Deep Regulatory Expertise and Proven Track Record
Legacy device manufacturers and new CE Applicants must consider associating with the I3CGLOBAL team for successful and fast medical device CER writing. The main reasons are the following:
- 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 Evaluation Report Writer who can plan and execute a clinical evaluation, meeting the regulations and guidelines per the manufacturers’ requirements.
- I3CGLOBAL’s collaboration among multidisciplinary teams, including clinical and regulatory professionals, ensures CER complied
- I3CGLOBAL’s expertise in PMS and PMCF ensures that all CERs include up-to-date real-world data, which is critical under MDR
- Experienced in various software tools enabling unmistakable, organized, and efficient ways of documentation.
- Experts at literature search and appraisal, interpretation and analysis of data.
- I3CGLOBAL utilizes proven methodologies for analyzing data and recording gaps in clinical evidence
- 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.
- I3CGLOBAL’s streamlined approach ensures efficient completion of CERs, reducing the time for technical file handover to NB.
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 is the ideal partner for medical device CER writing due to its regulatory expertise, proven track record, multidisciplinary team, and deep understanding of the MDR requirements.
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