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Scientific Communications

We can assist with your medical and scientific writing needs. Our scientific communications staff has the ability to interpret highly technical scientific subject matter to ensure clear, accurate, and concise written communication appropriate to your target audience.

Some of the projects we have assisted include, but are not limited to:

Clinical Evaluation Reports (CER)

  • We create complete CERs, in partnership with the manufacturer, that compile and synthesize information from disparate sources to provide a comprehensive picture of clinical use of your device, including:
    • Description of device and its use, along with regulatory history and device classification
    • Summary of clinical background for your device and its intended use(s)
    • Systematic, documented searches of available literature and medical reports to create a thorough review and evaluation of the relevant state of the art
    • Demonstration of equivalence to other device(s), if applicable
    • Summary of nonclinical testing data
    • Systematic, documented searches of  post-market surveillance data, clinical study reports, and other clinical data to create a comprehensive review of clinical experience of your device (or equivalent)
    • Medical review of the clinical evidence
    • Summary of device usability data
    • Explanation of the methods and parameters used to assess clinical benefits, safety, and the benefit-risk ratio
    • Summary of benefit-risk determination
  • Creation (in collaboration with the client) or update of a post-market clinical follow-up plan based on the evidence gathered
    • Design of post-market surveillance activities or clinical studies
  • Transition from European Union (EU) Medical Devices Directive, MEDDEV 2.7/1, to Regulation (EU) 2017/745 (known as MDR)

Ultimately, we can help you develop clinical evaluation plans and reports to maintain compliance with the latest European regulatory requirements.

Scientific Writing
Our scientific communications staff can assist with:

  • Creation of non-clinical test reports
  • Grant funding writing and editing

Medical Writing
Your documents can benefit from the expertise of our scientific communications staff and medical experts in:

  • Preparation of clinical study reports
  • Executive summaries of medical literature
  • Individual case histories (e.g., for Clinical Events Committee review)

Publication Support

Our scientific communications staff can also support you in:

  • Document optimization of English language use
  • Preparation of podium or poster presentation materials