Quality

We pride ourselves on our Quality Management System, which centers around our Quality Policy

MedSource Labs seeks to be a best-in-class provider of healthcare services, supplies and medical OEM products to our customers. We strive to maintain a culture of compliance to standards and regulations with a focus on continuous improvement based on our quality objectives to ensure the effectiveness of our quality system.

ISO 13485:2016 • Registered with the FDA • 510 (k) Cleared Products
• Private Branding • CE-Marked Products

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FAQs

What is MedSource Labs’ commitment to quality?

Our Quality and Regulatory Systems drive who we are and provide a strong foundation for product creation through our EMERGE process. MedSource Labs is continually improving its processes, products and services to ensure it consistently meets or exceeds customer expectations.

Could you describe your company’s Quality Management System?

At MedSource Labs, its Quality Management System adheres to U.S. and international standards.

What certifications and other premarket submissions has MedSource Labs met?

MedSource Labs is ISO 13485:2016 Certified, registered with the FDA and has cleared multiple 510(k) products.

How can MedSource Labs help with regulatory affairs?

The EMERGE process of MedSource Labs provides support to its clients with regulatory submissions to obtain clearance.

Do you provide your products and services internationally?

Yes, our products are available in several countries around the world.

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