Your Device Launch is Stuck in Legal -- We Build Compliant Sites That Ship
If you're a product manager watching FDA submissions pile up while your agency fumbles 510(k) templating, you need a dev partner who knows CFR 21 Part 820.
We build fast, compliant websites for medical device companies -- designed for FDA-class products, 510(k) portfolios, and surgeon-facing content.
Your product page goes live without the clearance number. A surgeon visits, finds no IFU download, leaves. Your sales team fields the same compliance question for the tenth time this week. Medical device website development builds platforms that serve regulated product data -- FDA classifications, therapeutic area filters, clinical evidence libraries -- to surgeon and patient audiences without tripping promotion rules. Your site needs modular catalogs that marketing can update without IT tickets, geo-aware rep finders that route leads correctly, and adverse event forms with audit trails that quality teams trust. The work stops short of guaranteeing FDA approval or replacing your regulatory counsel -- it builds the technical infrastructure so your compliance doesn't break at the template level.
What is holding your current website back?
Common gaps we find in nearly every audit.
How We Build This Right
Every safeguard, built in from Day 1.
FDA-Aligned Content Architecture
We structure product pages around FDA device classifications, indications for use, and cleared claims. Marketing edits within guardrails that block off-label statements by default.
HCP-Gated Content Portals
Surgical technique guides, clinical data, and other HCP resources sit behind NPI-verified or role-based authentication. Clean audience segmentation keeps you on the right side of FDA requirements.
HIPAA-Aware Infrastructure
All form submissions, contact requests, and adverse event reports are encrypted in transit and at rest. We deploy on SOC 2-compliant hosting with audit logging built in.
Accessible by Default (WCAG 2.2 AA)
Medical device websites need to work for users of all abilities. We build to WCAG 2.2 AA from the first commit -- not bolted on after launch.
Privacy-First Analytics
Cookie consent flows, IP anonymization, and GDPR/CCPA-compliant tracking are configured from day one. No dark patterns, no legal exposure.
Schema Markup for Medical Products
Structured data for MedicalDevice, Product, and FAQ schemas helps your devices appear in Google's rich results and AI overviews.
What We Build
Purpose-built features for your industry.
Organize device portfolios by clearance type without requiring developer intervention for every SKU change
Marketing updates device specs and launches new SKUs without waiting on IT ticket queues
Separate patient-facing content from HCP-gated resources to avoid off-label promotion flags
Surgeons find clearance data, IFUs, and clinical evidence on the first visit -- no sales follow-up needed
Deploy product pages that load in under 2 seconds on hospital Wi-Fi networks
Product pages rank for clinical search terms instead of sending high-intent traffic to competitors
Route adverse event reports to quality teams with HIPAA-aware form handling and full audit logs
Legal reviews pass faster because regulatory context lives in the CMS schema, not buried in PDFs
Publish multi-region content that adapts to EU MDR, Health Canada, and TGA requirements automatically
International distributors stop requesting one-off localized microsites -- your platform handles it
Integrate stock data and earnings releases into investor pages that meet SEC disclosure standards
Sales reps spend time closing deals instead of answering questions your website should've addressed
Built on a Modern, Secure Stack
Our Development Process
From discovery to launch. Quality at every step.
Regulatory & Content Audit
Week 1-2We audit your existing site against FDA promotional guidelines, HIPAA requirements, and accessibility standards. Every product page gets mapped to its clearance status and content gaps get documented.
Information Architecture & Content Model
Week 3-4We design the site structure around your device portfolio, clinical specialties, and audience segments. The CMS content model enforces regulatory guardrails by design.
Design & Prototyping
Week 5-7High-fidelity designs for key templates -- product detail pages, clinical evidence sections, HCP portals. Your regulatory and marketing teams review everything before a line of code ships.
Development & Integration
Week 8-12We build on Next.js with a headless CMS, connecting your CRM, ERP, or PIM as needed. Every page targets sub-1.5s load times and 95+ Lighthouse scores.
QA, Compliance Review & Launch
Week 13-14Accessibility audit, security penetration testing, and regulatory content review before go-live. Thirty days of post-launch support included.
Ready to discuss your your device launch is stuck in legal -- we build compliant sites that ship project?
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Explore related industries
200+ employee company? Complex multi-tenant, auction, or multi-location requirement? We have a dedicated enterprise capability track.
Get Your Free Medical Device Site Assessment
We'll review your current site and deliver a quote within 24 hours.
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