Quality Management Systems
(QMS)
Welcome to the world of medical device development, where the intersection of innovation and regulation is key to success. At MedLaunch, we understand that developing medical devices is not just about groundbreaking technology; it’s also about adhering to the highest standards of quality and compliance.
This adherence is not only a regulatory requirement but a commitment to safety and efficacy. Our expertise encompasses comprehensive quality systems and compliance with critical standards like ISO 13485, 21 CFR 820, and the EU Medical Device Regulation (MDR), ensuring that your medical devices meet and exceed global quality and safety benchmarks.
Setting Global Benchmarks for Safety and Quality
At MedLaunch, we pride ourselves on our ability to guide you through the intricate landscape of quality systems and regulatory compliance. Our approach ensures that your medical devices are not only compliant but set the standard for excellence in the healthcare sector.
Explore Our Expertise in Detail
Dive deeper into how MedLaunch can guide you through each aspect of medical device quality systems and regulatory compliance. Click below to learn more about our specific services and how we ensure your products meet these crucial standards.
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ISO 13485: Medical Devices - Quality Management Systems: Implementing quality management systems that adhere to the medical device industry's international standards.
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21 CFR 820 Compliance: Navigating FDA's Quality System Regulation, ensuring your devices meet all necessary U.S. requirements.
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EU MDR Readiness: Preparing your devices for compliance with the EU's rigorous Medical Device Regulation for market entry and sustained success.
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Labeling, UDI, and Symbols: Achieving clarity and compliance in medical device labeling, utilizing ISO 15223-1 standards and adhering to UDI requirements.