Quality

Medical Device Quality Management Software Systems

The Importance of Medical Device Quality Management Systems in FDA and ISO Environments

Manufacturers of finished medical devices made or sold in the United States must comply with GMP regulations enforced by the U.S. Food and Drug Administration (FDA). The Quality System Regulation or QSR (21 CFR 820) contains essential requirements that apply to medical device manufacturers, and it is the primary medical device regulation that the FDA enforces.

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Data Sheet: MasterControl Documents Data Sheet: MasterControl Change Control
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White Paper: 6 Must-Haves for a Quality Management System (QMS)
e-book: FDA and ISO Compliance for Medical Device Manufacturers

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Medical Device Quality Management Systems and FDA Regulations

Companies that are in the process of establishing their medical device quality management systems should address specific QSR requirements. The same thing goes for companies planning to use medical device quality management software; they must make sure that the software they choose offers features that comply with QSR requirements. Apart from FDA regulations, ISO 13485 is perhaps the most widely known quality standard that applies to medical device manufacturers. Just like QSR, ISO 13485 requires the establishment of effective medical device quality management systems.

Under QSR, medical device manufacturers must establish a quality system (otherwise known as medical device quality management systems) that should cover the following fundamental requirements:

Document Control:

Medical device quality management systems must include procedures for document distribution, changes, and approval, otherwise known as document control procedures.
Training Control:

QSR requires manufacturers to have sufficient qualified personnel - meaning employees with the appropriate education, background, and experience to do their jobs properly. In addition, manufacturers must provide procedures for identifying training needs and making sure that employees are trained accordingly. These training procedures are an important part of medical device quality management systems, whether they are manual systems or electronic systems using medical device quality management software platform.
Quality Audit:

Medical device manufacturers are required to establish audit procedures and conduct regular audits to ensure that their medical device quality management systems are compliant and effective. QSR requires the audit to be conducted by people who are not directly responsible for the processes being audited. Since audit is a recurring activity, manufacturers are increasingly relying on medical device quality management software solutions as the basis for their audit process and overall medical device quality management systems.
Corrective Action and Preventive Action (CAPA):

The section in QSR pertaining to quality audit requires the implementation of "corrective actions, including re-audit of deficient matters when necessary." While many device manufacturers continue to use manual (paper-based) medical device quality management systems, establishing an automated system based on medical device quality management software offers the capability to connect the CAPA process with the audit process in a way that is virtually impossible in manual processes.

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Medical Device Quality Management Systems and ISO Quality Standards

Manufacturers that comply with FDA regulations will find it easier to comply with ISO 13485 and vice versa because the FDA has harmonized QSR with ISO standards, making them complementary. Under ISO 13485, manufacturers must include the following in their medical device quality management systems:

Document Control:

Under ISO 13485, quality procedures must be documented, controlled, and effectively maintained. It is not uncommon for device manufacturers to be inundated in paperwork because practically everything they do must be documented and controlled properly. Document control is an essential requirement that has driven many manufacturers to switch from paper-based systems to automated medical device quality management systems that use medical device quality management software.
Training Control:

Just like QSR, ISO 13485 requires manufacturers to make sure that their employees are properly trained to do their jobs. Training needs must be regularly evaluated and employees' training records must be maintained. In establishing medical device quality management systems, manufacturers must integrate training control with the rest of their medical device QMS.
Corrective Action and Preventive Action (CAPA):

ISO 13485 requires "remedial" procedures, otherwise known as CAPA in the FDA environment. Specifically, it requires manufacturers to correct any instance of nonconformance that impact product quality and document the corrective action. The CAPA process is an essential component of an effective medical device QMS.

Using MasterControl to Establish Medical Device Quality Management Systems

Medical device companies throughout the world use MasterControl quality and compliance software as the platform for their medical device quality management systems. MasterControl is an end-to-end solution that automates and connects all quality processes critical to compliance with FDA regulations, ISO standards, EU directives, and other regulatory requirements.

Using MasterControl as the foundation for your medical device QMS will facilitate your compliance in all critical areas and help you with the following:

Establishing Medical Device Quality Management Systems:

Establishing and maintaining a medical device QMS is a basic requirement under FDA regulations, ISO standards and other rules and directives that apply to medical device manufacturers. MasterControl Documents™ provides a web-based electronic platform for a medical device QMS. It automates routing, review, and approval of documents, and provides a single location for all documents. It provides automatic revision control, so only the current version of SOPs and other documents are available in the system.
Complying with Training Control Requirements:

Proper personnel training is a key requirement under most regulations and quality standards. A medical device QMS must include a training control process that ensures regulatory compliance. MasterControl Training™ facilitates compliance by managing the training process more effectively; it automates the assignment of training tasks, distribution of training materials, testing, and verification.
Conducting Regular Audits:

Both QSR and ISO 13485 consider the audit process a critical aspect of medical device quality management systems. MasterControl Audit™ streamlines the audit process by automating all recurring tasks: scheduling of audits, sending out assignments, and tracking them. This module provides best-practice forms for gathering and tracking basic information, as well as for tracking audit findings. The system also provides analytics and reporting capability to make the audit process more transparent.
Integrating CAPA with Medical Device Quality Management Systems:

MasterControl streamlines the CAPA process by automating all CAPA-related documents and tasks, including routing, follow-up, escalation, and approval. MasterControl can integrate the CAPA process with other quality processes in a medical device QMS, so an approved CAPA might trigger a corresponding training course for all affected users, or it might trigger an SOP change if the corrective action is serious enough to warrant a modification of an existing SOP. MasterControl can also integrate with existing document repositories and enterprise applications.

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