MEDICAL DEVICE & HEALTH TECHNOLOGY

The regulatory partner your device program can't afford to skip

Empire HealthTech delivers expert regulatory documentation, clinical evidence packages, and strategic communications for medical device and health technology companies — built for long-term partnerships, not one-off projects.

Clinical Evaluations

EU MDR-compliant CERs, PMCF planning, and evidence strategy

Post-Market Surveillance

PMS plans, PMSR, PSUR - sustaining lifecycle compliance

Global Submission Prep

Technical files and dossiers for FDA, EU, and international markets

Communications

Whitepapers, publications, clinical claims, website copy, IFUs, SSCPs, and more

Expertise across
EU MDR / IVDR
FDA 510(k) & PMA
ISO 14971 Risk Management
Class II & III Devices
Software as a Medical Device (SaMD)
Wearables & Wellness Tech
Post-Market Surveillance
Clinical Evaluations
Expertise across
EU MDR / IVDR
FDA 510(k) & PMA
ISO 14971 Risk Management
Class II & III Devices
Software as a Medical Device (SaMD)
Wearables & Wellness Tech
Post-Market Surveillance
Clinical Evaluations

OUR SERVICES

Two domains. One expert partner.

We operate across two integrated disciplines so your regulatory documents and external communications always tell a consistent, credible story.

Built for Compliance
Regulatory & Technical Documentation

Submission-ready technical files, sustaining lifecycle documents, and clinical evidence packages built to withstand regulatory scrutiny — globally.

Clinical Evaluations (CEP, CERs)
PMCF Plans & Evaluation Reports
Post-Market Surveillance Plans & Periodic Safety Update Reports
Global Submission Documents
Technical Files (EU MDR / FDA)
Sustaining Regulatory Documentation
Telling Your Clinical Story
Strategic Health Communications

Evidence-based content that positions your technology credibly — for clinical, commercial, and investor audiences who need to understand your device's value.

Medical & Scientific Whitepapers
Website & Product Copy
Investor & Pitch Deck Content
Clinical Claims Support
Thought Leadership & Publishing
Conference & KOL Materials

WHERE WE'RE HEADED

Expert humans today.

Intelligent systems tomorrow.

Empire HealthTech is actively developing automation solutions that will compress regulatory timelines — giving device companies a faster path from development to market without compromising clinical rigor or compliance integrity.

NOW

Expert-led document services

Senior and principal regulatory partners embedded with your team as a long-term partner

NOW

AI-assisted workflows

Structured templates, evidence mapping, and gap analysis tools to accelerate delivery

NEXT

Regulatory automation platform

Senior and principal regulatory partners embedded with your team as a long-term partner

BUILT FOR

The companies building devices that matter

⌚
Wearables & Wellness Devices
Oura-style consumer health tech seeking clinical credibility and CE/FDA clearance
🩺
Diagnostic Technology
In-vitro diagnostics and point-of-care devices navigating IVDR and 510(k) pathways
🔬
Class II & III Implantables
Higher-risk devices requiring robust clinical evidence and PMS infrastructure
📱
Digital Health & SaMD
Software as a Medical Device scaling through EU MDR Annex XVI and FDA SaMD guidance

Ready to build a regulatory partnership that lasts beyond the submission?

Most engagements end at approval. Ours are designed to grow with your product - from first submission through post-market lifecycle management.