Regulatory + Compliance

Quality

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.

Certifications

FDA Registered

MedSource Labs has notified the FDA of its facility and the products we sell.

ISO 13485:2016

Internationally recognized standard that specifies requirements for a quality management system (QMS) specifically for medical devices.

510(k) Cleared Products

MedSource Labs currently has thirteen 510(k) cleared medical devices.

Internationally Registered

MedSource Labs is registered to sell products internationally.

FAQs

Q: 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.

Q: What is the company’s approach to Quality Management?

Our Quality Management System, inclusive of our SOPs, processes, and testing protocols, adheres and complies with FDA and international standards. Registered as a Specification Developer[1] with the FDA, our internal Quality team owns and manages our 510(k)s and design patents.

[1] https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee#specification

Q: What certifications and other premarket submissions has MedSource Labs met?

MedSource Labs is ISO 13485:2016 Certified, registered with the FDA with Specification Developer status, and holds multiple 510(k) products.

Q: Does MedSource Labs provide its products and services internationally?

Yes, MedSource Labs products are registered and available for sale in many countries including the United States, Canada, European Union, Brazil, Chile, and Vietnam. Please inquire about distribution opportunities for countries or regions not listed.

Our in-house product design and regulatory services through EMERGE are specialized in supporting clients with manufacturing in the United States, Colombia, and India. Contact our Quality team with questions.

Additionally, as the official correspondent with the FDA, we are positioned to act as the in-country representative for our manufacturing partners outside the U.S.