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.
專案失敗的原因
合規
FDA-Aligned Content Architecture
HCP-Gated Content Portals
HIPAA-Aware Infrastructure
Accessible by Default (WCAG 2.2 AA)
Privacy-First Analytics
Schema Markup for Medical Products
我們構建的內容
Organize device portfolios by clearance type without requiring developer intervention for every SKU change
Separate patient-facing content from HCP-gated resources to avoid off-label promotion flags
Deploy product pages that load in under 2 seconds on hospital Wi-Fi networks
Route adverse event reports to quality teams with HIPAA-aware form handling and full audit logs
Publish multi-region content that adapts to EU MDR, Health Canada, and TGA requirements automatically
Integrate stock data and earnings releases into investor pages that meet SEC disclosure standards
我們的流程
Regulatory & Content Audit
Information Architecture & Content Model
Design & Prototyping
Development & Integration
QA, Compliance Review & Launch
常見問題
Do you build websites that comply with FDA promotional guidelines?
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.
Can surgeons access gated clinical content on the site?
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.
How do you handle HIPAA requirements for medical device websites?
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.
What CMS do you use for medical device product catalogs?
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.
How long does a medical device website project take?
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.
Can you integrate our website with Salesforce or our ERP system?
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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