Services
Your Experts for Clinical & Regulatory Compliance
Supporting MedTech & Pharma from market entry through ongoing lifecycle compliance — aligned with MDR, IVDR, FDA, and international standards.
- 01Medical WritingAudit-ready technical and clinical documentation for MDR, IVDR, and FDA submissions.
- 02Strategic ConsultingRegulatory pathways planned, submitted, and maintained across the product lifecycle.
- 03Risk ManagementEN ISO 14971 risk systems — analysis, controls, benefit-risk, CER/PER integration and PMS.
- 04Training and MentorshipPractitioner-guided workshops and the Eagle Medical Writing Program.
- 05AssessmentMDR / IVDR readiness and pre-submission assessments of TD, CER/CPR, Risk Management and PMS.
- 06TemplatesSoonDetails coming soon.
Strategic Regulatory Writing That Withstands Scrutiny
Where each document sits in the product lifecycle
01 · Development
- Clinical Evaluation Plan
- Literature search protocol
02 · Submission
- CER (MDR) / CPR (IVDR)
- SSCP / SSP
- Technical documentation
03 · Post-market
- PSUR
- PMCF plan and report
- Vigilance reporting
DocliMed helps you create clear, audit-ready technical and clinical documentation for medical device and IVD manufacturers to secure efficient MDR, IVDR, and FDA submissions.
Supporting both EU and US regulatory pathways, our specialized medical writing team empowers medical device and IVD manufacturers to navigate MDR, IVDR, and FDA requirements with absolute confidence — from development phase through post-market lifecycle management.
Operating at the exact intersection of regulation, clinical and quality, we deliver robust documentation engineered to withstand rigorous regulatory scrutiny while ensuring efficient submissions, successful conformity assessments, and sustainability of the product lifecycle.
Clinical Evidence (MDR/IVDR)
Clinical Evaluation (MDR) & Clinical Performance (IVDR) support:
- Clinical Evaluation Reports (MDR) & Clinical Performance Reports (IVDR) — drafting, revision, remediation, and lifecycle maintenance
- Periodic Safety Update Reports (PSUR)
- Summary of Safety and Clinical Performance / Summary of Safety and Performance (SSCP/SSP)
- Systematic literature search across major scientific and vigilance databases — transparent methodologies and robust appraisal according to MDR Annex XIV, IVDR requirements, MDCGs and MEDDEV guidance
Regulatory and Clinical Strategy
Five governing principles shape how regulatory and clinical pathways are planned, submitted, and maintained across the product lifecycle — Strategic, Precise, Compliant, Agile, and Transparent.
Strategic
Regulatory pathways are aligned to business and clinical objectives from the outset — not bolted on after development decisions are made.
Precise
Submissions are built on data-driven evidence and exact documentation, leaving no ambiguity for reviewers to resolve.
Compliant
Every action is measured against current global standards, keeping the dossier defensible during audits and inspections.
Agile
The strategy adapts quickly as regulations, guidance, and market requirements shift, without losing course.
Transparent
Communication with Notified Bodies (NBs), Health Authorities is clear, timely, and fully documented at every stage of review.