Essential Quality Processes
Regulatory agencies, by law, require the implementation of Quality Management Systems to preserve public safety and ensure the manufacture of licensed or cleared products. When implemented properly, Quality Management Systems enable you to operate as a medical device or life science company, while achieving the auditable standards necessary to market your product.
At MethodSense, we’ve developed practical Quality Management Systems which achieve high levels of product quality and auditability.
It’s important to note that companies globalizing products across the pond must harmonize their Quality Management Systems with other regulations… ISO 13485 to 21 CFR Part 820 or vice versa. Companies are also increasingly required to integrate multiple regulations, such as HIPAA and other privacy regulations, to create a more streamlined and efficient system.