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Medical Device WebsitesFDA-Aligned UXHIPAA-Aware Infrastructure

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.

95+
Lighthouse Score
Performance target
<1.2s
LCP
Core Web Vitals
100%
HTTPS + SOC 2
Security baseline
$0
Compliance Gaps
On our watch
What Medical Device Website Development Actually Fixes -- And What It Won't

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.

Product pages missing 510(k) clearance data, IFU downloads, or regulatory context force sales teams to answer basic compliance questions the website should have handled.
Risk: Sales teams waste cycles answering basic compliance questions that the website should handle
Legacy CMS platforms that require IT tickets for every portfolio update are a bottleneck
Risk: New product launches stall while competitors publish faster.
Pages load slowly on hospital Wi-Fi -- exactly where surgeons browse
Risk: Bounce rates climb among your highest-value prospects.
No separation between patient-facing and HCP-gated content creates FDA flags for off-label promotion and audience mixing.
Risk: Regulatory flags from the FDA for off-label promotion or audience mixing
Cookie consent and tracking setups that fall short of GDPR or state privacy laws create legal exposure that compounds with every international page view.
Risk: Legal liability that scales with every international page view
SEO treated as an afterthought means product pages never rank for clinical search terms
Risk: Surgeons find your competitor's device first.

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

Next.jsSanityVercelTailwind CSSCloudflarePostHog

Our Development Process

From discovery to launch. Quality at every step.

01

Regulatory & Content Audit

Week 1-2

We 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.

02

Information Architecture & Content Model

Week 3-4

We design the site structure around your device portfolio, clinical specialties, and audience segments. The CMS content model enforces regulatory guardrails by design.

03

Design & Prototyping

Week 5-7

High-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.

04

Development & Integration

Week 8-12

We 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.

05

QA, Compliance Review & Launch

Week 13-14

Accessibility audit, security penetration testing, and regulatory content review before go-live. Thirty days of post-launch support included.

Social Animal

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Medical Device Websites from $14,000

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Related Resources

Frequently Asked Questions

Yes. We structure content models so marketing can only publish claims tied to cleared indications. Product pages include dedicated fields for 510(k) numbers, indications for use, and contraindications. We don't replace your regulatory counsel — we build the architecture that makes compliance the default rather than something you chase after the fact.
Absolutely. HCP portals use role-based access verified by NPI number, professional email domain, or manual approval. Surgical technique videos, clinical data, and HCP promotional materials stay separated from patient-facing content, keeping your FDA compliance clean.
We deploy on SOC 2-compliant infrastructure with TLS encryption for data in transit and AES-256 at rest. Form submissions — including adverse event reports and patient inquiries — route through encrypted pipelines. Audit logging and access controls are configured from the start, though we recommend pairing this with a formal HIPAA risk assessment from your compliance team.
We typically work with Sanity or Contentful as headless CMS platforms. Both support structured content models that map directly to your device portfolio — by therapeutic area, clearance class, and clinical specialty. Marketing gets an intuitive editing interface. Regulatory gets content validation rules baked into every field.
Most projects run 10 to 14 weeks from kickoff to launch. The timeline depends on catalog size, integration complexity, and how many regulatory review cycles your team needs. We front-load the content architecture and compliance audit so development moves quickly without rework.
Yes. We regularly integrate with Salesforce, HubSpot, SAP, and custom PIM systems. Rep finder tools, lead routing, and product data sync are all common integration points for medical device companies. Integration scope gets defined during the audit phase — no surprises mid-build.
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200+ employee company? Complex multi-tenant, auction, or multi-location requirement? We have a dedicated enterprise capability track.

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