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It should come as no surprise that success in medical devices means overcoming compliance challenges.
The business case for quality compliance is undeniable – quality affects every stakeholder in the medical value chain. From patients and healthcare providers to distributors and regulators, trust in a product is built on its proven safety, effectiveness, and reliability.
Quality is a central concern from product design through manufacturing and marketing. Every stage — from research and development, to raw material selection, to precision engineering and final delivery — is governed by strict international standards.
Ultimately, compliance is more than a checkbox — it is a culture of excellence that drives innovation, reduces risks, and builds long-term trust in the marketplace.
We are proud to provide medical products of the highest quality, confirmed by international standards and approvals:
We are certified according to ISO 13485, the international standard specifically designed for organizations involved in the design, production, and servicing of medical devices. This proves our responsibility and commitment to strict regulatory requirements and patient safety.
Our products are registered and authorized for sale in the United States, demonstrating their safety and effectiveness. This ensures that our devices fully comply with FDA regulations, including pre-market approval processes such as 510(k).
Our products carry the CE mark, confirming full compliance with the requirements of the European Union. The Certificate of Free Sale guarantees that our devices are legally marketed in the country of origin and can be exported internationally without restrictions, facilitating access to global markets.
Global Recognition: Our certifications are respected and recognized worldwide.
Maximum Safety: Every stage — from quality control to distribution — follows international standards.
Export Flexibility: With the Free Sale Certificate, our products can be easily registered and imported abroad.
Your Peace of Mind: By choosing products with these certificates, you trust proven quality and safety.
