Medical Writing and Publication Planning

We offer strategy and planning of publication pipelines that effectively demonstrate the clinical and economic outcomes of your medical products. We also provide comprehensive medical writing services, including Clinical Evaluation Packages, manuscripts.

EU MDR CLINICAL EVALUATION REPORTS

We provide full service medical writing of required Clinical Evaluation packages and manuscripts.

This includes Clinical Evaluation Plans and Reports (CEP, CER), Summary of Safety and Clinical Performance (SSCP), Post Market Clinical Follow Up Plans and Reports (PMCF), Product Safety Update Reports (PSUR), Annual Summary Reports (ASR), helping you demonstrate compliance of your medical devices with EU MDR, and conformity with the MDD regulations to secure CE marking for your medical devices in EU, and establish compliance to similar rules in other regions.

MANUSCRIPT WRITING

Our skilled team collaborates with you and the study investigators to present clinical study data in clear and compelling scientific manuscripts.

These manuscripts are aligned with ICMJE guidelines. Once we are engaged early on, we engage in the discussion of the clinical study data, and establish a streamlined process for author invitation, outline generation, draft and review of high-quality manuscripts, journal submission, and response to reviewers.

Exquisite Biomedical led us through authoring and publishing a key manuscript. They are organized, knowledgeable, and on top of things. Importantly, they exhibit patience and grace while working with our team which has very little experience in the process. They are a true partner in achieving our goals. We look forward to using their services on future projects!

Valencia Technologies