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Lead with an integrated approach
to bring successful products to market
Develop with confidence
by using systematic, rigorous development methodologies
Launch with Compliance
by leveraging established development processes
At Strategies for Medtech, our vision is crystal:
forging partnerships that bring world-class technologies to market, collectively charting the course to a healthier global future
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strategic planning
Business Leadership
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Cross-functional integrated program leadership
Start-up Strategy
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Single cohesive strategy integrating Market Assessment/Access/Pricing, Product, Quality, Regulatory and Clinical
R&D Product Development
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User Needs gathering
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System Requirement Definition
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Concept Generation & Selection
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S.M.A.R.T. Requirement Assessments
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Decomposing System Requirements to Product Requirements
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Robust Design Methodologies
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Design Verification Readiness
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Design Output Capability Analysis
Quality
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Design Control (CFR 820)
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Top-down Hazard Analysis
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User risk analysis (uFMEA)
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Design Risk analysis (dFMEA) ISO14971
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Risk Control Measures
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Test Method Validation (GR&R)
Regulatory/Clinical
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RA pathway identification (510k, PMA, De Novo, IDE)
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Notified Body Engagements
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Rest of World (ROW) regulatory registrations for Health Canada, PMDA, TGA and other global markets
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Strategic remediation leadership
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EU MDR (2017/745)
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Technical Documentation Remediation
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CER, PMCF, SSCP, PSUR
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