QUALITY

Quality Management System

Certified ISO 13485:2016

Our proven quality management system is the result of over 60 years in the labor and delivery room product sector. It  is continuously audited for performance improvements, managerial effectiveness, and resource waste. This is a critical component of why Stork® has lead the industry in safety, quality and reliability since 1958. All of our quality management system processes from Design Control to Product Surveillance are managed in-house.

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World-Class Medical Suppliers

We only partner with suppliers that meet and exceed our rigorous standards for premium quality and unrivaled reliability in each and every product. Our diverse base of trusted suppliers strengthens our ability to carry out our mission of serving the needs of our pediatric patients with first-class quality products.

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Quality of Manufacturing

Our success in manufacturing the highest quality labor and delivery room products on the market stems from our unrivaled experience. With over 60 years of leading the industry, we work relentlessly to create dynamic systems and processes that improve product performance and reliability while reducing product costs by eliminating waste. Manufacturing systems and processes are closely monitored and tested because we make all of our products right here in the USA.

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FDA Approved & CE Certified

Our medical device product quality, reliability and safety are recognized through our FDA clearances and CE certification.

Quality Excellence

Our products have been used world-wide, in over 100 million successful births. With this success rate, healthcare professionals since 1958 have trusted Stork® as the leader in quality and reliability for products used in the labor and delivery room. Every single product from Stork® that makes it into the delivery room is rigorously tested well above the acceptable industry testing requirements. Our reputation to strive for perfection in all of our products provides peace of mind and confidence when bringing a precious life into this world.

We have a commitment to ensure we are delivering state-of-the-art products that meet globally recognized, harmonized standards. Our products are designed, annually audited and certified to meet ISO 13485 Quality Management Systems, ISO 14971 Risk Management, and ISO 10993 biocompatibility standards for medical devices.

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Our Quality Standards