Quality System

At Medical Designs, LLC, we continuously look for ways to improve the welfare of our customers. We diligently monitor and improve the quality of the products and services we deliver to exceed our customers’ expectations and international standards of quality. We focus on our customers’ needs and use their input to identify products and services that excel in addressing their expectations.

Medical Designs’ comprehensive Quality System is designed to provide a framework to ensure quality of medical products and services and to assure conformity to all relevant standards and regulations at all stages of company operations.

In our pursuit of quality, we intend not only to set the highest possible standards, but also to provide the processes, procedures, and training that will ensure our standards are met. We accomplish this by embracing the following elements into our Quality System:

• Continuous improvement through use of strategies and processes to prevent quality problems;
• Understanding our customer’s needs as well as the consequences to our customer if we do not perform to prescribed standards;
• Involving suppliers and distributors in the process of quality improvement;
• Maintaining education and training as vital tools to promote quality improvement;
• Empowering employees to facilitate decision making and implementation;
• Analyzing information and data to solve and prevent problems.

The Medical Designs, LLC Quality System has been designed to comply with all applicable requirements of FDA’s Quality System Regulation (21 CFR Part 820), Medical Devices- Quality management systems-Requirements for regulatory purposes (ISO13485:2016) and Canadian Medical Device Regulation (SOR/98-282).