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Regulatory Expertise

Literature review, clinical evaluation, PMS, and submission for
EU MDR, IVDR, and FDA

Regulatory Guidance

One expert team to help you from search to submission
Literature
CER
Surveillance
Vigilance
Strategy
Literature Review
Comprehensive, submission-ready literature reviews with a 100% acceptance rate from notified bodies. Audit response included with every engagement.
Core Components
Database search - PubMed, Embase, Cochrane, ClinicalTrials.gov, and more
Aligned to MEDDEV 2.7/1 Rev 4 and MDR Article 61
Formatted to your CER templates and SOPs
Full-Service
End-to-end execution — search, screening, appraisal, writing, and delivery
DIY Templates
MDR-ready templates with expert annotations for independent teams
Device coverage:
Class I–III
IVD
Software as Medical Device
Combination Products
Clinical Evaluation Reports (CER)
MDR-compliant CERs written by experienced regulatory professionals with a dedicated writer, clear timeline, and audit defense included. Engagements remain active through final certification.
Core Components
Dedicated writer and project manager from day one
Standard delivery in 8–12 weeks, rush in 5–6
CER drafting, clinical data integration, and benefit-risk analysis
Full audit defense included
Full-Service CER
End-to-end execution — literature review, writing, revisions, audit defense, and delivery
Staff Augmentation
An experienced writer embedded in your existing workflows, templates, and SOPs
Device coverage:
Class I–III
IVD
SaMD
Drug-Device Combos
FDA 510(k)
Post-Market Surveillance
Stay MDR-compliant after market. We handle adverse events, PSURs, PMCF, and vigilance — on schedule and audit-ready.
Core Components
Adverse event and recall monitoring
MDR-compliant PSUR drafting
PMCF strategy and reporting
PMS plan development or gap remediation
Device coverage:
Class I–III
IVD
Software as Medical Device
Combination Products
Vigilance Monitoring and Reporting
We monitor adverse events and recalls across your entire device portfolio and deliver classified reports on your schedule — weekly, monthly, quarterly, or annually.
Core Components
Global database monitoring for adverse events and recalls
Flexible reporting cadence — weekly through annually
Full adverse event classification and export review
Centralized dashboard with trending analysis and full archive
Full-Service
We search, review, and deliver reports on your chosen cadence — fully managed
Platform Access
View all AE data, reports, and trending in your centralized CiteMed dashboard
Device coverage:
Class I–III
IVD
Software as Medical Device
Combination Products
Regulatory Strategy, Submissions and Gap Analysis
Leverage real submission experience across device types and markets. We provide gap assessments, submission-ready documentation, and active support throughout the regulatory review process.
Core Components
EU MDR / IVDR Technical File and submission strategy
FDA 510(k) and De Novo submission preparation
Gap assessment against current MDR, IVDR, or FDA requirements
Notified Body liaison, deficiency response, and audit management
Market entry planning across EU and US
Device coverage:
Class I–III
IVD
SaMD
Combination Products
Drug-Device Combos

Commitment

Every review delivered clears Notified Body audit. Audit response is included

at no additional cost, and engagements remain active through final certification.
100% Notified Body Acceptance
Every review delivered will clear Notified Body audit.
Audit Response Included
As Notified Bodies raise questions, 
CiteMed responds together with the client at no additional cost
Active Through Certification
Engagements close when the certificate 
is issued – not when the document is delivered
Process
Getting started to certification is just a few simple steps.

Our team supports the process with a single point of contact and regular weekly updates.

Kickoff

Align on scope, timeline, and requirements
and the work starts the same week.

Research

Execute search, screen literature,
integrate clinical data, and build the draft.

Review

Operationalize feedback, do final check, 

and document is ready for submission.

Support

Join Notified Body review, support deficiency responses,
and stay with the team through audit and certification.

Kickoff

Align on scope, timeline, and requirements
and the work starts the same week.

Research

Execute search, screen literature,
integrate clinical data, and build the draft.

Review

Operationalize feedback, do final check, 

and document is ready for submission.

Support

Join Notified Body review, support deficiency responses,
and stay with the team through audit and certification.

Who We Help

From first-time submissions to managing a global device portfolio, we scale
to meet the needs of our customers.
Startups
First CER or first submission and no internal regulatory team
SMB
Growing portfolios with MDR transition deadlines and limited writer capacity
Enterprise
High-volume, multi-market programs that need consistent, scalable output
SaMD
AI, diagnostic, and digital health navigating EU AI Act and MDR Article 22
CROs
Trusted overflow partner for literature review capacity and CER execution
Freelancers
Search infrastructure, validated templates, and expert QA support

Let's Talk

We’ll provide a zero cost consultation and guide you through scope.
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