REGULATORY SERVICES

Getting & staying compliant

From your first submission to sustaining documentation years post-approval — Empire HealthTech embeds with your team to produce the regulatory documents your device program depends on.

EU MDR

FULL COMPLIANCE COVERAGE

FDA

510(K), PMA, & DE NOVO

4-6 week

TYPICAL CER TURNAROUND

Lifecycle

SUSTAINING DOC PARTNERSHIPS

Most regulatory engagements end at the submission. Ours don't. We build long-term partnerships with device and health technology companies — becoming the team that knows your product, your history, and your regulatory strategy as well as you do.

WHAT'S INCUDED

Regulatory & Clinical Technical Documentation

Every document we produce is submission-ready, evidence-based, and built to withstand scrutiny from FDA, notified bodies, and competent authorities globally.

Most requested
Clinical Evaluation Reports (CERs)

Rigorous, EU MDR Annex XIV-compliant CERs that consolidate clinical evidence, appraise literature, and demonstrate the clinical safety and performance of your device.

What's included
Clinical background & device description
Systematic literature search & appraisal
Equivalence assessment (if applicable)
Clinical evidence summary & conclusions
PMCF gap analysis
Post-Market Surveillance

Comprehensive PMS plans and reports that satisfy EU MDR Article 83–86 obligations and demonstrate ongoing safety and performance monitoring.

What's included
PMS Plan (PMSP)
Post-Market Surveillance Report (PMSR)
Periodic Safety Update Report (PSUR)
PMCF Plan & Evaluation Report
Vigilance & complaint trend analysis
Global Submission Documents

Technical dossiers and submission packages prepared to meet the requirements of FDA, EMA, and international markets — structured for first-pass approval.

What's included
510(k) & PMA submission packages
EU Technical Documentation (Annex II/III)
Summary of Safety & Clinical Performance (SSCP)
Declaration of Conformity
Multi-market dossier alignment
Sustaining Regulatory Documentation

Ongoing document management and updates to keep your technical file current — covering design changes, label updates, new evidence, and periodic reviews.

What's included
Technical file gap assessments
Design change impact documentation
Label & IFU updates
Annual regulatory review
Audit readiness support

HOW WE WORK

From brief to submission-ready

01
Discovery & scoping
We review your device, classification, intended markets, and existing documentation to define the exact scope and timeline.
02
Evidence & gap analysis
We identify what clinical and technical evidence exists, what's missing, and what strategy will best satisfy regulatory requirements.
03
Document production
Our writers produce submission-ready documents with structured review cycles and your team's input at every stage.
04
Review & handoff
Final documents are delivered with a full quality check, version control, and an optional sustaining partnership for ongoing updates.
Standards & frameworks
EU MDR 2017/745
EU IVDR 2017/746
FDA 510(k)
FDA PMA
ISO 14971
ISO 13485
MEDDEV 2.7/1 Rev 4
MDCG Guidelines
SaMD / IEC 62304
IMDRF Guidance
EU AI Act
MDSAP
21 CFR Part 820 / QMSR
IEC 60601
UDI Requirements
Standards & frameworks
EU MDR 2017/745
EU IVDR 2017/746
FDA 510(k)
FDA PMA
ISO 14971
ISO 13485
MEDDEV 2.7/1 Rev 4
MDCG Guidelines
SaMD / IEC 62304
IMDRF Guidance
EU AI Act
MDSAP
21 CFR Part 820 / QMSR
IEC 60601
UDI Requirements

Not sure where your
documentation gaps are?

We offer a complimentary scoping call to review your current technical file, identify what's missing, and outline exactly what we'd recommend — with no obligation to proceed.

BOOK A SCOPING CALL