From blueprint to bedside—safety and effectiveness, built in with confidence.
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Clinical risk & safety expertise for medical device or software products powered by robust analysis, clear strategies and proven derisking methods.
Clinical Risk & Safety
Risk assessments to identify safety gaps using tools such as Fault Tree and Root Cause Analysis.
Proactive clinical reassessment using tools such as FMEA and Hazard & Harms analysis to mitigate failures during product development.
Guide your product development in line with current patient safety best practices and leveraging post market data.
Support usability studies including protocol development.
Assist with UI/UX review for devices and software including SiMD & SaMD.
Ensure work aligns/complies with medical device global standards*
Post-Product Development & Medical Affairs
Post-market complaints review and signal detection
Risk minimization measures such as educational materials, labeling updates etc.
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 to leverage drive product adoption.
Benefit risk re-assessment with any changes in the device or emerging risks.
Corrective and Preventive Action (CAPA) support.
Regulatory Services
Review product and materials for regulatory submission.
Clinical defense for regulatory submissions with deep knowledge and applications medical device standards and guidance including AAMI -TIR and FDA.
Review labeling content (instructions for use, package inserts, electronic labeling, symbols.) in alignment with global regulatory standards*
VistaCrest believes in teaching and empowering your teams the why and the how of medical device safety, further instilling the safety culture during all stages of development.
Standards/Regulatory bodies: AAMI -TIR, ISO 14971, 13485, IEC 62304, IEC 62366, FDA 21 CFR Part 801, EU MDR, ISO13485, IEC 60601-1, Notified Bodies etc.
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