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

Submission Documents

Technical Files and Dossiers for FDA, EMA, and international markets

Communications

Whitepapers, Publications, Summary of Safety and Clinical Performance

Clinical Studies

Investigator's Brochures, Clinical Study Reports, and actionable evidence

Expertise across
EU MDR
FDA 510(k) & PMA
ISO 14971 Risk Management
Class II & III Devices
Software as a Medical Device (SaMD)
Expertise across
EU MDR
FDA 510(k) & PMA
ISO 14971 Risk Management
Class II & III Devices
Software as a Medical Device (SaMD)

OUR VERTICALS

Two practices. One embedded partner.

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

Regulatory & Technical Documentation

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

Clinical Evaluation Plans & Reports (CEP, CER)
PMCF Plans & Evaluation Reports (PMCF Plan, PMCF Report)
Post-Market Surveillance Plans & Reports (PMS Plan, PMSR, PSUR)
Performance Evaluation Plans & Reports (PEP, PER)
Clinical Study & Investigation Reports (CSR, CIR, PSR)
Investigator Brochures (IBs)
Technical Files (EU MDR / FDA)
Global Submission Documents (GSSD)
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

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?

BOOK A DISCOVERY CALL