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Our goal at VistaCrest is to mitigate potential medication errors in technologies used in healthcare delivery. We aim to provide high quality work in the most efficient and cost-effective manner. We enjoy learning about new products and then rolling our sleeves to identify opportunities based on the company needs. Our knowledge and skills are built from bedside clinical experience, medical devices and software including regulated products. See our services below.
Product Development
Proactive risk assessment to identify any safety gaps.
Guide your product development in line with current patient safety best practices.
Knowledge of medical device standards and guidance including AAMI -TIR and FDA.
Human Factors Evaluation.
Support usability studies including protocol development.
Review of Instructions for Use and customer education content.
Assist with UI/UX review for software including SaMD.
Post-Product Development & Medical Affairs
We work with you to understand your product and intended audience.
Curriculum development and educational materials.
Gap analysis and clinical risk assessment based on realistic use scenarios.
Assess and improve messaging and strategy.
Market analysis, evidence generation & data analysis to understand customer needs.
Provide insights and leverage them to influence adoption of products.
Regulatory Services
Review product and materials for regulatory submission.
Clinical Defense for Regulatory Submissions.
Knowledge of medical device standards and guidance including AAMI -TIR and FDA.
To work with us, contact us here.
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