In the United States, a government agency called the Food and Drug Administration (FDA) establishes regulations that govern the sale of food, drugs, biologics and medical devices. FDA requires that manufacturers in these industries establish and maintain quality systems to ensure that their products meet the usability and safety needs of their customers. Quality systems for products that are governed by the FDA are based on Good Manufacturing Practices or GMPs.
The GMP compliance requirements for medical devices are outlined in the Code of Federal Regulations (CFR), most prominently in the FDA Quality System Regulations of 21 CFR Part 820. This part establishes the requirement for quality systems in medical device companies, mandating quality procedures such as design controls, CAPA process, quality assurance
The GMP requirements also include other portions of the CFR. 21 CFR Part 812 deals with investigational device exemptions, allowing devices to be shipped lawfully for the purpose of clinical investigations when they would otherwise be required to comply with a performance standard or to have premarket approval. 21 CFR Part 808 addresses exemptions from Federal regulation of state and local medical device requirements.
Even for medical device companies that qualify for the exemptions described in 21 CFR Parts 808 and 812, GMP compliance activities will be centered around the FDA quality system regulations outlined in 21 CFR Part 820. Medical device companies are required to establish and maintain a quality management system that is appropriate for their device and meets the guidelines for GMP compliance. Quality system requirements include:
Design Controls - Medical device manufacturers are responsible for establishing and maintaining procedural control of the design of their devices to ensure that specified design requirements are met. The Design controls process includes design and development planning, design inputs and outputs, design review, design verification and validation, design transfer, design changes, and the compilation of a design history file.
Document Controls - Medical device manufacturers need to maintain control of documents that are produced to satisfy the GMP compliance guidelines. Documentation within the quality system must be approved by the designated person, and any changes to documents in the quality system must be approved as well. Quality documentation should be available at all locations where they might be used or necessary, and obsolete documents should be removed from all points of use.
Production and Process Controls - Manufacturers are required to develop, control and monitor their production processes to ensure that their devices conform to the specified requirements. The process of proactively preventing manufacturing defects through process monitoring is known as quality assurance.
In all, there are 15 Subparts of 21 CFR Part 820 with additional regulations that mandate corrective and preventive actions (CAPAs), acceptance activities for devices, supplier controls and more. Only medical device companies that meet all GMP compliance requirements may sell their devices in the U.S..
Greenlight Guru's Quality Management Software Platform is purpose-built to facilitate GMP compliance specifically for medical device companies. Alternative methods to quality management, such as paper-based systems make it virtually impossible for device manufacturers to remain 100% compliant with GMP. Reason being, documents are often stored in filing cabinets or other physical locations, preventing personnel to manage the proper control of documents.
Greenlight Guru offers a secure, cloud-based eQMS platform that connects the major subsystems of quality, such as Multi-level Design Control, Risk Management, and CAPA management. These automated workflows provide superior accessibility to product development documents and streamlines processes while simultaneously supporting regulatory compliance. Greenlight Guru makes it easy for medical device manufacturers to achieve GMP compliance, pass audits and inspections, and get safer quality medical devices to market faster.