We support companies active in medical devices, in-vitro diagnostics, dietary supplements, and pharmaceuticals with:
• CE certification in compliance with MDR/IVDR
• Preparation of technical documentation
We work with manufacturers, importers, startups, and investors—especially those who:
Yes. We work with companies at every growth stage—from startups to established brands. Our services are step-by-step and adapted to your current readiness.
No. We operate internationally, with a strong focus not only on the EU but also on Gulf markets such as the UAE, Oman, and Saudi Arabia.
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Yes. We are flexible and provide both project-based and ad hoc consulting—for instance, for a specific CE certification or export strategy.
🔎 [Learn more about CE and MDR compliance]
The CE mark confirms that a product meets EU safety, health, performance, and environmental requirements. It is mandatory for:
ℹ [Learn more about CE certification]
This depends on:
If your product is medium- or high-risk (Class IIa, IIb, or III), a Notified Body assessment is required.
We can assess your product and advise accordingly.
You will need:
Yes. We recommend Notified Bodies based on product type, risk class, and target market. We also assist with:
MDR (Regulation 2017/745) has replaced MDD with stricter requirements, including:
Yes. Our MDR support includes:
PMCF (Post-Market Clinical Follow-up) involves collecting real-world performance data after market entry. It is mandatory for high-risk medical devices under MDR.
PMPF (Post-Market Performance Follow-up) applies to IVD products and helps update the Technical File with real-world performance data.
The CE technical file must include the following:
• Product description and specifications
• Risk analysis and risk management plan
• Performance and safety test results
• Clinical or performance evaluation
• PMS, PMCF, or PMPF plans
CE-related costs depend on:
• Product type and risk class
• Need for a Notified Body
• Number and type of required tests
• Consulting and documentation fees
Typical costs range from several thousand to tens of thousands of euros.
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Fees are based on project scope, documentation volume, and product readiness.
We offer transparent, customizable packages.
Not necessarily. In most cases, appointing an EU Authorized Representative is sufficient.
Under MDR/IVDR, a legal representative in the EU is mandatory for non-EU manufacturers.
✅ We provide this service.
In addition to CE marking, you may also need:
📚 See the complete guide to exporting medical equipment to Europe
Yes, we offer the following services to companies seeking exclusive representation of prestigious international brands:
Yes. Our international trade consulting includes:
Absolutely. Based on your market and production capacity, we offer:
Yes. We deliver expert training in:
It helps you:
Through legal consulting and document review, you can:
Yes. With our global market knowledge, we help you:
Yes. With our global market knowledge, we help you:
We are in direct contact with most European Notified Bodies and can make your product registration process faster, more accurate and hassle-free.
Our goal is not just to issue certificates – we pave the way for you to export legally and safely.
📩 For a free initial consultation, contact us now.
Are you having trouble on the road? We are with you.
Contact us today so that no obstacle stands in the way of your legal export.
International consultant for medical, laboratory and pharmaceutical products
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