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The FDA is tasked with regulating the sale of medical devices throughout the United States. To ensure that medical devices sold in the USA are both safe and effective for their intended use, the FDA maintains quality system regulations (QSR) that must be followed by all medical device manufacturers who wish to sell devices in the USA. These regulations are described in 21 CFR Part 820 and include the essential requirements for a quality system along with other legal requirements for manufacturers.
21 CFR Part 820 establishes the quality system mandate for all medical device manufacturers in the USA. Each manufacturer is required to establish and maintain a quality system that is appropriate for the medical device that they manufacture, and that meets the requirement of this legislation. The FDA QSR mandates the following requirements for medical device companies:
Quality Policy - Executive managers must establish a quality policy and objectives for maintaining product quality. The policy must be understood, implemented and maintained throughout the organization.
Organization - Management must establish and maintain an organizational structure which ensures that medical devices are produced in accordance with the FDA QSR. This includes establishing responsibility and authority for all persons who manage, perform, and assess work affecting quality, and the provision of resources to meet the requirements of the FDA QSR.
Management Review - Executive managers must review the suitability and effectiveness of the overall quality system at defined intervals, documenting the dates and results of the quality system reviews. The reviews must ensure that the quality system meets the requirements of FDA QSR on an ongoing basis.
Quality Planning - A quality plan must be produced by each manufacturer which defines the quality practices, resources and activities that must be conducted to satisfy the requirements for quality set out in the FDA QSR.
Quality System Procedures - Each manufacturer must establish and maintain a set of procedures and instructions for implementing the quality system throughout the organization.
The FDA conducts quality audits to ensure that medical device manufacturers in the United States are compliant with 21 CFR Part 820, but manufacturers are also required to conduct their own internal audits to assure that the quality system is in compliance with the established QMS requirements, and to establish the overall effectiveness of the quality system.
Medical device manufacturers must create and maintain reports of the results of each quality audit, including a re-audit of any items found to be deficient and records of any corrective actions taken.
Greenlight Guru’s Quality Management Software platform helps medical device manufacturers maintain compliance with FDA QSR by providing a secure, accessible storage location for all documentation related to the manufacturer's quality systems. The Greenlight Guru eQMS creates a single source of truth for your entire organization, helping to ensure that the organizational structures which maintain quality procedures are observed and that all of your team members can access the company's quality policy, procedures and instructions.
Greenlight Guru also supports document control and document management for the many documents produced within the quality system, including audit results, design controls, purchasing controls, the CAPA process, and more.
Looking for an all-in-one QMS solution to advance the success of your in-market devices and integrates your quality processes with product development efforts? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software →