Global Medical Device Regulatory Support
Regulatory Support for Medical Device Companies Targeting the EU Market
Kalitekit supports international medical device manufacturers with MDR documentation readiness, ISO 13485 quality system alignment, UDI strategy, EUDAMED data preparation, label/IFU review and technical file gap analysis.
MDR Documentation
Technical documentation, Declaration of Conformity, GSPR, risk management and evidence structure.
UDI & EUDAMED Data
Basic UDI-DI, UDI-DI, EMDN, device data mapping and bulk XML preparation support.
Label & IFU Consistency
Review of label, symbols, intended purpose, warnings and regulatory consistency.
About Kalitekit
Kalitekit is a regulatory and quality consultancy brand focused on medical device compliance, technical documentation and structured data preparation for EU market access.
We help companies transform complex product information into clear, reviewable and submission-ready documentation and data packages.
For Manufacturers
Support for manufacturers preparing technical files, labels, IFUs, UDI data and EUDAMED registration data.
For Export Teams
Practical support for companies planning to sell medical devices in the European market.
For Regulatory Teams
Gap reviews, documentation alignment and structured checklists for internal regulatory preparation.
For Large Catalogues
Excel-based UDI/Device data mapping and EUDAMED bulk XML preparation for high-volume product lists.
Our Core Services for International Companies
A focused service portfolio for medical device companies that need practical, structured and commercially useful support before entering or expanding in the EU market.
EUDAMED & UDI Support
Preparation and review of device registration data for EUDAMED workflows.
- Basic UDI-DI review
- UDI-DI / GTIN data check
- EMDN code review
- Bulk XML preparation
MDR Technical File Gap Analysis
Structured review of MDR documentation readiness before audits, submissions or commercial expansion.
- Annex II / III structure check
- GSPR evidence table review
- Risk management file review
- Declaration of Conformity check
Label & IFU Review
Review of product labels and instructions for use for regulatory consistency and MDR alignment.
- ISO 15223-1 symbol check
- UDI and CE marking consistency
- Warnings and intended use review
- Manufacturer / AR data check
ISO 13485 Readiness
Support for quality management documentation and process alignment under ISO 13485 expectations.
- QMS document gap review
- Procedure and form structure
- CAPA and complaint process review
- Supplier and production controls
EU Market Entry Review
A practical first review for companies asking “What do we need before selling in Europe?”
- Product classification check
- Economic operator readiness
- Required documentation roadmap
- Risk-based action plan
Documentation Package Preparation
Preparation and formatting of professional regulatory documents, checklists and evidence files.
- Technical file index
- GSPR checklist
- Risk analysis templates
- Audit-ready documentation structure
Why This Matters Now
EUDAMED readiness is becoming a practical business requirement for companies placing medical devices on the EU market.
The first four EUDAMED modules become mandatory from 28 May 2026, including Actor and UDI/Devices registration.
Incorrect device names, UDI fields, EMDN codes or risk class data can create registration delays and rework.
Manual entry becomes difficult for companies with hundreds or thousands of UDI-DIs.
Labels, IFUs, DoC, GSPR, technical files and EUDAMED data should tell the same regulatory story.
Request a Free Initial Review
Tell us about your medical devices, target market and current regulatory status. We will review your request and suggest the most suitable next step.
Need help preparing for the EU medical device market?
Start with a free initial review and let us identify the most practical regulatory, documentation or EUDAMED data preparation route for your company.