Medical Writing

Our team’s extensive clinical and regulatory background coupled with excellent writing skills results in having a talented professional medical writer on your team!

Writing

Medical Writing

We pride ourselves on our ability to critically assess your clinical evidence. We prepare analysis and summarization of results culminating in a well written document, suited to the needs of your audience. Our documents are second to none.

We have written hundreds of CERs and PMCF documents, starting with MEDDEV 2.7.1/3 and MEDDEV 2.12 to current MDR requirements.

We prepare many clinical documents in addition to  clinical evaluation reports. These include manuscripts, clinical study reports, regulatory submissions, and annual reports. We’ve supported products in several medical areas including cardiology, urology, brain stimulation, neurostimulation, infusion pumps, peripheral vascular, wound care and urinary incontinence.

Our focus on quality, flexibility, and collaboration leads to high-quality deliverables and ensures efficient and accurate documentation.

Our Medical Writing Services Include:

Create Clinical Evaluation Plans (CEP)

Write Clinical Evaluation Reports (CER)

Perform Literature Searches

Write Post Market Clinical Follow-up Plans and Reports (PMCF)

Write the State-of-the-Art section (SOTA)

Write the Summary of Safety and Clinical Performance (SSCP)

Statistical Analysis

Medical Writing Team
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