Quality Management Systems (QMS)
Medical Device Quality Management Systems
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, including 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 makes certain that your medical devices are compliant while raising the bar 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 explore our services and see how we position your products to meet these crucial standards.
- ISO 13485: Medical Devices – Quality Management Systems: Implementing quality management systems that adhere to the medical device industry’s international standards.
- 21 CFR 820 Compliance: Guiding you through FDA’s Quality System Regulation so your devices meet all necessary U.S. requirements.
- EU MDR Readiness: Preparing your devices for compliance with the EU’s rigorous Medical Device Regulation for market entry and sustained success.
- Labeling, UDI, and Symbols: Achieving clarity and compliance in medical device labeling, utilizing ISO 15223-1 standards and adhering to UDI requirements.
We don’t just talk about getting results; we deliver them. See how MedLaunch helps medical device companies overcome complex challenges and bring innovative products to market.
Turning an Outdated Product Into a Modern Market Success
Solving Regulatory & Supply Chain Challenges to Keep a Life-Saving Product on the Market
Every great device deserves a clear path to market.
Connect with MedLaunch today and take the first step toward approval and success.