Quality Control

ISO-Certified Quality Control for Precision Medical Devices

Medical device manufacturing equipment used by MK Precision.MK Precision is committed to delivering the best quality products for our clients. As a contract manufacturer of medical equipment, we guarantee the quality of our products through the implementation of an ISO-certified Quality Management System that defines customer requirements and uses statistical analysis, process validation, lean manufacturing and high-yield machining to deliver medical devices of superior quality with efficiency and accuracy.

Each step of the MK Precision lean manufacturing process is as important as the medical device being made and the client being served. Integrating statistical analysis into proven systems, our contract manufacturing team is able to determine solutions to potential problems before they arise.

MK Precision monitors the manufacturing process and ensures the quality of its products through state-of-the-art machines and expert engineers who are dedicated to process validation and quality control. From contract initiation to product fulfillment, our unwavering attention to detail results in high-yield machining and unsurpassed product quality. Clients can rest assure that our finished products will meet their needs and are backed by both ISO 9001:2008 and ISO 13485:2003 certificates.

 

FDA and ITAR Registered

In order for MK Precision to manufacture high quality products, we ensure that our facility is compliant and registered with various organizations. We are registered with the Food and Drug Administration (FDA) as a medical device provider which means our establishment is involved with the production and distribution of medical devices intended for commercial distribution in the United States. This registration is a safe guard for our clients because of the FDAs trusted name and is an honor for our facility to boast its approval.

 

MK Precision is registered with the International Traffic in Arms Regulations (ITAR) because we serve the aerospace industry that involves articles, services and related technology designated as space-related by the United States federal government. This registration gives the government the necessary information on who is involved with certain manufacturing products because we design and manufacture state-of-the-art components for the aerospace industry. Being registered with ITAR gives our facility more credibility because we only manufacture products with the highest of standards in mind.

If you have any questions about our manufacturing process or any of our certificates and registrations, please contact us and we will be happy to talk with you.