IT for Medical Device Sector
Medical device companies operate under ISO 13485, EU MDR (for EU market), TİTCK regulations in Türkiye, with design controls, traceability and document management at the heart of operations. The IT layer must support these regulated workflows.
ISO 13485 Posture
Document control, design records, audit trail.
MDR Awareness
EU MDR-aligned posture for EU market participation.
Design Controls
Design history file, DMR, change control IT support.
Long-term Retention
Device lifecycle records — design through post-market.
What's different about medical devices
- ISO 13485 — quality management system for medical devices.
- EU MDR / IVDR (for EU market) — comprehensive regulation with significant documentation.
- TİTCK regulations — Türkiye Medicines and Medical Devices Agency oversight.
- Design controls — design history file, device master record, change control.
- Traceability — UDI (Unique Device Identification), serial numbers, lot tracking.
- Post-market surveillance — vigilance reporting, complaint handling.
Frequently chosen with this service
Licenses commonly selected on the same project — each product page has comparisons, FAQ and a quote/cart.
Frequently Asked Questions
Document control (SharePoint with versioning, approval workflow), audit log retention, change control records, training records. We deliver the IT layer; the QMS itself is owned by the company's quality team.
SharePoint structure organized per design control phase, with retention spanning device lifecycle. Sensitivity Labels for design IP. Audit log on access. For very large design records, specialist PLM tools may complement.
For Türkiye-only market, TİTCK regulations apply. For EU market participation, EU MDR adds significant documentation, post-market surveillance, EUDAMED interaction. We support the IT layer; regulatory work is done by qualified MDR consultants.
Clinical trial data, post-market complaint data may include patient identifiers. Treated as KVKK Article 6 (special category) with explicit consent, Sensitivity Labels, restricted access, audit log.
How Xen Bilişim delivers IT for Medical Device Sector
- 1. Discovery: Stakeholder interviews, current-state inventory, compliance review and risk mapping; deliverable: written discovery report.
- 2. Plan: Target architecture, SKU/licence selection, migration plan and SLA scope documented; quote signed.
- 3. Implement: Phased rollout with pilot → full deployment; user training and runbook delivered; KVKK/ISO compliance evidence collected.
- 4. Operate: Continuous monitoring, quarterly health-checks, incident response and roadmap reviews — under MSP retainer or project-end transfer.
Typical end-to-end timeline: 4-6 weeks (varies by scope).