Who Writes a Clinical Evaluation Report?
If you’re a medical device company, writing an accurate and MDR-compliant clinical evaluation report (CER) is vital to the success of your product in the medical device market. But, where do you find a CER writer, and who is qualified to write a CER in the first place? In this post, we will discuss these and other related aspects of writing a clinical evaluation report, as well as the qualities you should look for when hiring a CER writer.
Who Writes a Clinical Evaluation Report?
A CER can be written by your company’s in-house staff, an external consultant, a contract research organization, or a freelance technical writer.
A Medical Device Company’s In-House Staff
This could be a team of people or just one person–the advantage of having your in-house staff write a clinical evaluation report is that they’re already familiar with your product and the company. They know your product’s features and benefits, as well as your target audience; in-house staff can also provide valuable insights into the clinical evaluation process. In-house staff may sit too close to the products and their bias may reduce the overall efficacy of the clinical evaluation report,
If you don’t have in-house staff who are qualified to write a CER, you can hire an outside consultant. The advantage of hiring a consultant is that they bring an outside perspective to the table and can provide an objective view of your product and offer suggestions on how to improve the clinical evaluation process. Outside consultants can be expensive and may need time to thoroughly learn the products in a comprehensive manner.
A Contract Research Organization (CRO)
A CRO can be a viable option if you don’t have the time or resources to write a CER yourself. CROs are experienced in writing CERs and can often get the job done more quickly and efficiently than a medical device company’s in-house staff. As with external consultants, costs of employing CRO services can add up and time is required to fully bring a CRO up to speed with product nuances.
A Freelance CER Writer
Hiring Freelance CER writers is another option that you can consider. The advantage of choosing a freelance writer is that they’re usually more affordable than the other options; however, the downside is that you may not get the same level of quality or expertise as you would from a consultant or CRO.
You should consider your budget and needs when choosing a CER writer. If you have the time and resources to write a CER yourself, then creating the CER internally is probably the best option. However, if you don’t have the time or resources to write a CER, then you may want to consider hiring a consultant, CRO, or freelance writer. Let’s look at some of the qualities of a proficient CER writer.
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What Are the Qualities to Look for in a CER Writer?
When hiring a CER writer, you should look for someone who has:
- Experience in writing CERs–the most important quality to look for in a CER writer. When a CER writer has experience in writing CERs for medical device companies, they are already familiar with the process and requirements outlined in the regulations.
- A medical or scientific background–this knowledge helps them grasp and compose the science behind your product. Without a medical or scientific background, a CER writer may not be able to understand the clinical data you provide or write a good literature review for clinical research, which is a critically important part of the clinical evaluation.
- Excellent writing skills–a good CER writer will have excellent writing skills. They should be able to clearly and concisely communicate complex information.
- Attention to detail–CER writers should also be detail-oriented. They should be able to review clinical data and identify any errors or discrepancies in it.
- Ability to meet deadlines–time management is crucial, and an efficient CER writer should be able to meet deadlines. They should be able to work quickly and efficiently to get the job done on time.
- Regulatory knowledge–the writer you hire should have a solid understanding of MEDDEV 2.7/1 rev 4, which is the guidance document for clinical evaluations. They should also be familiar with other relevant regulations, such as the Medical Device Directive (MDD), and the Medical Device Regulation (MDR).
What Is the Cost to Hire a CER Writer?
Hiring a freelance CER writer can cost you anywhere between $65 an hour to $85+ an hour, but this can vary widely depending on the writer’s experience, qualifications, and location.
Of course, a professional consultant or CRO will cost more than $85 an hour–there’s a wide range of prices in the market, and it’s a good idea to conduct thorough research to find the best option for you.