What is EU MDR?
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What is European Medical Device Regulation?
The European Medical Device Regulation (EU MDR) is one of the most comprehensive and stringent medical device regulations globally. It replaced the former Medical Device Directives (MDD) to enhance the safety, performance, and transparency of medical devices.
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Why is MDR Compliance Important to You?
Highest Standards of Safety and Quality: Our products adhere to the stringent requirements of the MDR in every aspect, including design, manufacturing, clinical evaluation, and post-market surveillance, ensuring the safety and reliability of the products you use.
Lifetime Traceability & Continuous Improvement: The MDR emphasizes monitoring product safety and performance throughout its entire lifecycle. This means we continuously track product performance and optimize it, providing you with lasting assurance.
Leading the Global Regulatory Trend: Embracing MDR compliance signifies that our products are at the forefront of international regulations, preparing them for entry into high-standard global markets.
How We Meet MDR Regulatory Standards
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How Do We Ensure MDR Compliance?
Rigorous Quality Management System (QMS): We have established a comprehensive QMS compliant with ISO 13485 international standards, ensuring product quality from the outset.
Comprehensive Technical Documentation: We maintain a detailed technical documentation file for each product, covering all aspects of design, testing, risk management, and clinical evaluation, demonstrating compliance with MDR's General Safety and Performance Requirements (GSPR).
Post-Market Surveillance Mechanism: We implement a strict post-market surveillance plan to continuously collect product performance data from the market, ensuring ongoing compliance with the highest safety and performance standards.
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Advantages for Your Business by Choosing Our MDR-Compliant Products.
Reduced Risk: MDR-compliant products effectively lower your procurement risks and patient safety risks.
Enhanced Reputation: Utilizing products that meet the highest international standards will elevate your institution's professional image and client trust.
Regulatory Confidence: Our MDR compliance provides you with solid regulatory confidence, no matter your location.
