We provide system, control, software, and electrical engineering expertise focused on medical devices. We provide pharmacokinetic / pharmacodynamic modeling for new and existing pharmaceuticals. We also have experience developing combination device/drug products.
We provide years of expertise in the development, analysis, reporting, and publication of clinical trials for both medical devices and pharmaceutical research from proof-of-concept studies through post-market clinical follow-up studies.
We have the scientific background to understand your product or solution. When it comes to a medical writing team, whether it be for a clinical evaluation report, regulatory submission, white paper, or peer review publication, our scientific expertise gives you a high quality product.
Our team has many years of experience working within regulations from the FDA (CFRs), European Union (MEDEV, MDR, ISO), and international standards (ISO 60601, ISO 10993, ICH, HIPAA and GCPs). We can help your team navigate these regulations and standards.