Our team’s extensive clinical and regulatory background coupled with excellent writing skills results in having a talented professional medical writer on your team!
Today’s medical device industry is a complex and evolving regulatory environment. Our expertise in regulatory and medical writing can help you navigate this complexity. 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:
Clinical Evaluation Strategy Development
Creation of MDR Documentation such as:
- Clinical Evaluation Plans & Reports (CEP, CER)
- Summary of Safety & Clinical Performance (SSCP)
- Post Market Clinical Follow-up Plans & Reports (PMCF P, PMCF R)
Prepare Manuscripts & Clinical Study Reports
Evaluation of PMS Data
Conduct Scientific Literature Searches
State-of-the-Art Summary (SOTA)
We are your subject matter experts!
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