Support for Device Companies

Whether you work in medical affairs, clinical research management, or research administration, you seek to publicize data supporting your therapies’ efficacy.

SME provides a truly comprehensive guide to clinical publishing. In addition to assisting with publication of prospectively collected data, we also work with affiliated clinical practices to create databases that generate several retrospective, relevant papers on existing therapies.

We provide a broad range of services to Medical Device Companies, including:

Comprehensive research and publication support to medical affairs departments

Data-driven whitepapers, graphics, and promotional materials generation for clinical marketing

Literature reviews and technical writing for regulatory teams

We augment the capacity of regulatory affairs departments by providing literature reviews and technical writing for:

European Clinical Evaluation Reports, MedDev 2.7.1 Rev. 4 compliance.

510(k), IDE, and PMA submissions to the Food and Drug Administration.

Canadian Health Protection Branch submissions.

Comprehensive research support entails:

Physicians and biostatisticians who are available at any point in the research process to provide high-level feedback on study design, data collection and interpretation, and teaching points.

Broad-ranging support services for affiliated clinician researchers, from literature reviews and figure generation to comprehensive manuscript drafting and data extraction and interpretation, diminish the activation energy of writing, leading to faster publication of crucial data

Neurovascular-focused Mandarin and French translation services.

We augment the capacity of regulatory affairs departments by providing literature reviews and technical writing for:

Data scientists compile existing medical literature

Biostatisticians analyze, understand, and prepare your internal data

Medical writers and developers create a custom graphic, whitepaper, or other promotional material

Publishing ethics are VERY important to us. We strictly follow all ICMJE guidelines governing authorship.