Who We Are
Your partner in compliance excellence. With proven success supporting medical device startups, we simplify regulatory complexity and empower teams to launch safely and scale confidently.
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Expertise in ISO 13485, 21 CRF Part 820, and EU-MDR pathways​
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Strategic audit preparation and risk-based remediation
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Local support in the Boston medtech ecosystem
What We Do
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Audit Readiness Smart automation tools + pre-audit coaching
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QMS Setup & Optimization Scalable quality systems tailored to your product
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Risk Management Strategy Proven tools aligned with ISO 14971
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Design Control Remediation Gap analysis and tactical fixes
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Global Market Compliance MDSAP & EU MDR navigation
Client Success Stories
Case Study: TechMed Solutions
Assabet's depth of knowledge and experience saved us hundreds of hours.” “They helped us building the QMS from scratch - it wasn't even difficult!” “They speak regulatory, but also startup. That’s rare."
A startup improved compliance records through our guidance.
Growth
Client achieved product launch after regulatory approval.
Innovation
