At NoCode, we build experiences beyond code, at the intersection of humans and intelligent systems. We focus on real productivity, real alignment, and real work in the world.
Focus Area
AI Medical Device Regulatory Compliance & Quality System Platform
Core Features & Capabilities
Automated Medical Quality Management (eQMS): Automates FDA eQMS compliance, ISO 13485, and EU MDR filings.
Regulatory Submissions Automation: Drafts 510(k) submissions, technical files, and design history files (DHF).
Automated Risk Management & CAPA: Tracks corrective actions, audit logs, and medical device risk assessments.
Best For
Reducing time on routine knowledge work
Centralizing team workflows with AI assistance
DesignersHR Professionals
Architecture & Security
Enterprise MedTech SaaS: Fully GxP, HIPAA, 21 CFR Part 11, and ISO 27001 compliant platform.
Pricing Details
Enterprise Custom: Annual subscription pricing calibrated per medical device classification and company size.
Quick Info
PricingSubscription
ComplexityBeginner
DeploymentCloud
Time to ValueFew minutes
API AvailableNo
Free TrialNo
Open SourceNo
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