Who It's For
- Manufacturers preparing for MDR/IVDR obligations
- Device teams requiring PMS and vigilance workflow maturity
- Organizations restructuring technical file ownership
- Companies needing QMS/SOP alignment support
Service
Medical Devices | Malta-based EU Pharmacovigilance Headquarters for Global End-to-End Execution
Clynico delivers Malta-based EU medical device support with global operational coordination across the full product lifecycle. We help teams strengthen MDR/IVDR readiness, PMS and vigilance routines, technical documentation controls, and post-market execution discipline.
What We Deliver
- MDR/IVDR readiness support and gap closure planning
- PMS plan and PMS report support
- Vigilance workflow support and complaint handling workflows
- Technical file structure support
- Clinical evaluation coordination support
- SOP and QMS alignment support
Our Operating Model
- Step 1Discover: current-state MDR/IVDR and PMS posture
- Step 2Scope: remediation priorities and governance model
- Step 3Build: workflows, templates, and responsibility matrix
- Step 4Validate: internal readiness checks and evidence review
- Step 5Maintain: recurring updates and vigilance controls
Standards & Best-Practice Alignment
- MDR/IVDR-aware documentation structure
- PMS and vigilance evidence traceability
- Complaint handling workflow discipline
- QMS-linked SOP control and review cycles
Pitfalls We Prevent
- Fragmented PMS evidence across teams
- Unclear vigilance escalation handling
- Technical files with inconsistent architecture
- Late remediation cycles close to review points
- SOP misalignment with actual operations
FAQ
Can you support both MDR and IVDR portfolios?
Yes. We support both frameworks with implementation-focused documentation controls.
Do you write technical files end-to-end?
We provide technical file structure and coordination support alongside your accountable teams.
Can you help with complaint process design?
Yes. We build workflow controls for intake, triage, escalation, and traceability.
Do you provide notified body services?
No. We provide readiness and operational support; conformity assessment remains with designated notified bodies.
How fast can we start?
Onboarding intake can begin within 48 hours, followed by a scoped delivery plan.
Related Services
Take The Next Step
Build Defensible MDR/IVDR Operations
Book a compliance call to map your PMS, vigilance, and documentation controls.