SGS Certification Alternative for Medical Devices
Hardware Compliance is an AI-powered SGS certification alternative that automates FDA 510(k) and CE marking documentation so hardware teams get to market faster.
SGS Is Slowing You Down
Months Lost in SGS Queues
SGS timelines stretch for months, and every week waiting is a week you are not shipping or closing deals.
Documentation Built From Scratch
Assembling FDA 510(k) and CE marking technical files manually costs tens of thousands in consultant fees before testing even starts.
Rigid Process Misses Your Product
SGS workflows were not built for robotics, drones, or novel hardware categories that span multiple standards at once.
Hardware Compliance Handles Your Entire Compliance Workflow
Provide your product specs and target markets. Hardware Compliance's AI agents identify every applicable FDA, CE, FCC, or UL requirement, draft your full technical documentation package, and connect you with the right accredited testing lab.
A Faster Path From Product to Certified
Hardware Compliance replaces the slow, opaque SGS process with an AI-driven workflow that covers research, documentation, lab matching, and tracking in one platform.
AI Research
Surface Every Applicable Requirement Fast
Hardware Compliance's AI agents analyze your product specs against thousands of pages of FDA, CE, and other standards to surface every requirement with full citations. Replaces weeks of manual research or expensive SGS pre-assessments.
- Full regulatory citations
- Product-specific analysis
- Minutes not weeks
Documentation
Auto-Generate Technical Compliance Files
Hardware Compliance auto-generates the complete technical file package required for FDA 510(k) submissions and CE marking technical documentation. No more assembling docs from scratch or paying consultants by the hour.
- FDA 510(k) ready files
- CE marking technical files
- Declaration of conformity
Standards Coverage
One Platform for Every Standard
From FDA 510(k) and CE marking to FCC, UL, ISO, and IEC 62368-1, Hardware Compliance covers every standard your product needs across US, EU, and other markets from a single platform instead of juggling multiple certification bodies.
- FDA and CE in one place
- FCC UL ISO IEC coverage
- Multi-market requirements
Human Oversight
Expert Sign-Off Before Lab Submission
Industry professionals review and validate all AI-generated documentation before it goes to the lab. For high-stakes FDA 510(k) and CE submissions, you get AI speed with human accountability and sign-off.
- Professional document review
- Pre-submission validation
- Reduced rejection risk
Lab Network
Match With the Right Accredited Lab
Hardware Compliance matches your product with the right NRTL or accredited testing lab based on your specific standards, product category, and geography. No cold-calling labs or relying on SGS referrals to find the right testing partner.
- NRTL accredited labs
- Matched by standard and region
- No cold-calling required
Frequently Asked Questions
Skip the SGS Queue and Get Certified Faster
Book a call with our team to see exactly what your certification path looks like and how Hardware Compliance can accelerate it.
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