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
FAQs
Q
What is MedSource Labs’ commitment to quality?
A
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.
Q
Could you describe your company’s Quality Management System?
A
At MedSource Labs, its Quality Management System adheres to U.S. and international standards.
Q
What certifications and other premarket submissions has MedSource Labs met?
A
MedSource Labs is ISO 13485:2016 Certified, registered with the FDA and has cleared multiple 510(k) products.
Q
How can MedSource Labs help with regulatory affairs?
A
The EMERGE process of MedSource Labs provides support to its clients with regulatory submissions to obtain clearance.
Q
Do you provide your products and services internationally?
A
Yes, our products are available in several countries around the world.
