The United States FDA mandates that all medical device companies that market product in the U.S. maintains a quality system that is subject to audit by FDA inspectors. In 21 CFR Part 820, the FDA establishes the requirements for the quality system - it explains what the policies and procedures in the quality system should cover, but not what the policies and procedures should be.
A quality system is the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management. You create these policies yourself, based on your business needs, the customer's needs, the perceived risk of your device, the specific requirements of your device, and in compliance with FDA regulations.
A quality management system is the set of tools that your company uses to manage the quality system, verifying and validating its ongoing effectiveness at satisfying the needs of your customer.
It used to be that medical device companies consisted of a quality manager and filing cabinet, but today, a solution like Greenlight Guru's QMS Software can be implemented to effectively streamline the quality management process, helping you get to market even faster.
Can you imagine what a quality management system would look like before software solutions were available to manage the file folders full of documents produced by an effective QMS (if you're all too familiar, start here)? As recently as ten years ago, medical device companies would keep whole filing cabinets full of documents - documents for design controls, documents for CAPA, photographs and engineer's drawings, policies for suppliers, manufacturing, and everything else. Greenlight Guru's QMS Software brings your quality management system online and makes it the single source of truth, leading to great organizational benefits.
Greenlight Guru’s QMS Software Supports CAPA & Process Improvement - The corrective and preventive action (CAPA) process is the heart of an effective QMS. This set of policies and procedures governs how an organization will assess feedback about
Greenlight Guru’s QMS Software Promotes Effective Product Development - The goal of an effective product development team is to create a product that meets identified user needs and is both safe and effective for its intended use. Medical device companies implement Design Controls, a crucial set of QMS processes, to ensure that product development follows the needs of the user without getting off track. Greenlight Guru helps by providing a single platform where your engineers can securely store and access all of the documentation produced in the product development process. Keeping your Design Controls organized is so important because the data generated in product development feeds into other documents later on - your 510k submission, device master record, and design history file, to name a few. With a software-based QMS, you'll never misplace or lose track of the most important documents related to your device.
Greenlight Guru QMS Software Creates Staff Accountability and Engagement - Greenlight Guru's QMS Software allows anyone at your organization to find and reference the policies most relevant to their role. By establishing and documenting controls for supplier management, production processes, labeling, packaging, handling, and even storage of your product, you maintain complete centralized control over the products that you create.
Your organization's quality management system is the architecture that you build to show all the activities you do that comply with quality regulations. The FDA created the mandate for what processes should exist for quality at your medical device company, but it's ultimately up to you to assign roles and responsibilities, and carry out your processes in a way that mitigates risk for the customer and your business.