Design with Compliance in Mind.
Fixing compliance after R&D costs 10x more. Embed Strategy, Cybersecurity, and Risk Management from Day 0 to ensure a zero-rework launch.
The Challenge
Devs focus on features. Regulators focus on 'Design Controls.' Great tech fails without the right paperwork history.
The Solution
Translate code into compliance. We set up an R&D environment where your coding workflow automatically generates the required documentation.
Key Value Propositions
Strategic Clarity
Prevent wrong turns from the start. We define classification and testing requirements early to scope development clearly.
Secure by Design
Security isn't an afterthought. We embed it into your architecture to meet the latest cybersecurity guidelines.
Agile Compliance
We provide a hybrid process that resolves the conflict between Agile development and Waterfall regulatory requirements.
The Solution Package
Core components included in this package.
Regulatory Pathway Strategy
Roadmap and budget estimation.
RegIntel AI
Monitoring standard changes during development.
Cybersecurity Threat Modeling
Initial architecture security review (STRIDE).
Risk Management Files
ISO 14971-based risk analysis design.
Traceability Connector
Jira/Git integration for traceability management.