If you are an innovator developing a device, it is critical to understand the purpose and innerworkings of quality management systems and quality management reviews for medical devices. A Quality Management Review (QMR) is a process required by international standards (e.g., ISO 13485) and regional regulations (e.g., 21 CFR 820). These reviews are deemed fundamental to support a suitable, adequate, and effective Quality Management System (QMS) needed in the development and post-market monitoring of a novel medical device. The QMS is a formalized set of interrelated documents, procedures, and responsibilities, created to ensure an adequate level of quality throughout the lifecycle of a medical device product and service (figure 1).
The Purpose of Quality Management Review for Medical Devices
The key aims of the Quality Management Review for medical devices are:
- To ensure consistent compliance with customer and regulatory requirements.
- To improve QMS effectiveness and efficiency on a continuous basis. This is key, as the QMS sets the foundation for making medical devices that are available to end users, safe and effective.
- To highlight emerging trends within the company. These can range from manufacturing (e.g., non-conforming products) and post market activities (feedback, complaints, PMCF etc.), to internal quality processes (e.g., failure to follow development processes, hence potential to deliver defective devices to market).
Figure 1. Key Components of a Quality Management System (QMS)
Quality Management Reviews focus heavily on data and information collected over time (a pre-defined observation period). However, they are also a forum for
forward-thinking communication. During reviews, attendees are encouraged to analyze data, identify opportunities for improvement, and express any other need for optimizations in the medical device development process. For example, these can be changes to the QMS objectives or quality policy.
The Quality Management Review for medical device is a unique opportunity to unite a cross-functional group of Subject Matter Experts (SMEs) and Top Management. Here, the combined expertise allows a thorough assessment of the quality of the organization’s activities, in relation to the lifecycle management. Thus, a focus on quality is one of the key responsibilities of Top Management. Despite busy schedules, a summarized yet comprehensive review is an excellent tool to ensure quality is maintained and actions can be taken swiftly.
How To Manage a Quality Management Review for Medical Devices
Depending on company size, the maturity of its QMS, and number of occurring issues in the system, we recommend the Quality Management Review occur at a quarterly or bi-annual frequency. This is an important occasion for de-risking the company strategy, by identifying existing issues. Start-ups or smaller companies with disruptive products, may benefit from more frequent meetings. This is because their medical device technology is novel, quality processes may not be well-established, and data analysis is vital.
Consequently, regular meetings serve as a critical moment to check for quality issues affecting the medical device. They are the occasion to call the attention of the management to blocking issues. Decisions may require management buy-in or sign off. Management must then decide on appropriate steps for escalated issues, whilst ensuring alignment with the company strategy.
To determine the frequency of QMRs, it is also important to consider time delays for resolution. For example, is it appropriate to wait to communicate to senior managers about an issue observed 12 months prior? The agility of a company’s response to issues is often a reflection of the overall quality culture. Quality should be management’s priority. Thus, their frequent involvement and responsiveness will ensure the company adheres to the standards. Moreover, the company will suffer less over time, de-risking product performance in the field and increasing productivity.
Finally, we do not generally recommend lower review cadence, unless there are other frequent formal communications covering quality information review and analysis – where Top Management is actively involved. Nevertheless, there are methods to decrease meeting overload and increase work efficiency.
Optimizing Review Frequency
Here we cover two key examples for optimizing the frequency of Quality Management Review meetings:
- Quality Management Review frequency can be aligned with other corporate meetings. Additional senior management reviews may be assessment of financial results, business risk and compliance, clinical governance, information security, etc. Often this data is closely correlated to the information required in a Quality Management Review, so there is an opportunity to consolidate information exchange into fewer meetings. This approach helps connect quality to other parts of the business, optimize meeting frequency by minimizing overlap in meetings, and spark discussion which fosters a good quality culture.
- Quality Management Review efficiency can be improved through stakeholder alignment on input data. For example, Corrective Actions Preventive Actions (CAPAs) are governed by a procedure created for analyzing, correcting, and preventing (re-)occurrence of issues. This concept is needed in all business areas for various reasons, regulatory and good business practices. To increase efficiency, CAPA information should be standardized to fit all stakeholder requirements. This allows rapid information filtering when data needs to be pulled for a specific purpose, e.g. a Management Review or a due diligence activity. Overall, workload can be reduced for both those providing the input into reviews and those analyzing the information.
The Importance of Data in Quality Management Reviews and Beyond
It is important to efficiently summarize how the QMS has performed over a defined time-period. This can be achieved via establishing appropriate metrics and thresholds showcasing the processes’ health. In addition, Post Market Surveillance metrics must also be collected around the medical device performance and conformity, as required by regulations.
Quality process metrics may assess the process’ overall effectiveness and any positive/negative trends. Here we list common metrics and illustrative examples, which are non-exhaustive:
- The number of non-conformities raised per procedure/ topic/ business unit. E.g. The number of repeated issues with document evidence of adherence to training requirements across different company functions.
- The adherence to timelines set by regulations and internal procedures. E.g. Whether reporting timelines for serious incidents under the Medical Device Regulation (MDR) 2017/745, article 87 are consistently met.
- The type, frequency, number and status of complaints received and their link to risk management. E.g. The monthly frequency in complaints associated with use errors. More specifically those requiring investigation and updates to usability engineering and risk management files.
- The type, frequency, and number of returns from customers or the service team. E.g. The number of returns marked as faulty and later confirmed to be meeting specifications, highlighting potential deficiencies in training and supporting documentation.
- The regional variations observed in the data. E.g. In cases where activities are contracted out to third parties for certain regions, or user profiles are significantly different in terms of culture, literacy levels, etc.
Quality metrics should provide key data, such as the status, time, region, and occurrence rates. This provides insights into process optimizations, or the need for further resources, such as human, tools and system/ infrastructure.
Organizing Quality Data into Reports
Furthermore, quality data should be consolidated into dashboards or reports. This creates a means to efficiently analyze this dynamic system. Reports can provide highlights and lowlights for periods between meetings and keep the Management Review team informed. This will also significantly help prepare the data for other reports including, Post Market Surveillance (PMS) reports and Periodic Safety Update Reports (PSUR). Finally, audit preparation efforts can also be reduced, since this information is important to auditors looking to to assess samples from a QMS. Having data readily available is reassuring, because it shows control and understanding of requirements.
Whilst frequency of Quality Management Reviews should be correlated with the selected metrics, the objective is to look at the bigger picture as supported by the detail. It is often essential to conduct more frequent reviews of some metrics. For example, it is critical to ensure complaints are addressed in a timely manner. This means minimizing delays in each step: assessments, exchanges with regulators and users, decision making, and final resolution.
However, not all metrics need to be assessed weekly or monthly. Many metrics will only be looked at as part of Management Review. Nevertheless, it is key to define appropriate cadence to monitor each parameter measured, and establish threshold alerts for urgent issues. These need to be assessed immediately, so that control is maintained or regained quickly. Otherwise, issue may significantly affect end users or the business. In the case of complaints, a single issue can result in serious patient harm, and if unnoticed/ untreated could also end up in litigation against the company.
Quality Management Review Key Components
For proper set up of a management review process, it is important to research and review standards and regulations for which your organization claims compliance. Key reference documents for Quality Management Reviews in medical device organizations include:
- The International Standard: ISO 13485. It communicates information on Quality Management Systems for medical devices and the requirements for regulatory purposes.
- The Medical Device Single Audit Program: MDSAP AU P0002.007 Audit Approach . It includes references to applicable requirements from participating jurisdictions.
These will help set up the framework of your agenda.
Depending on how the remainder of the QMS has been established, it may be key to revisit existing procedures. This ensures that if an escalation/communication occurs through Management Review, the information is reflected in the template for the Management Review agenda and the procedure. Consequently, a smooth handover between processes can happen.
Additionally, it is also good practice to keep the agenda consistent and familiarize attendees with a standardized structure. Moreover, it is important to set expectations on the types of deliverables that can result from such a meeting (table 1).
Table 1. Examples of Topics Covered in Quality Management Reviews
Who Should Attend Quality Management Review for Medical Device
The Quality Management Review should involve professionals from various disciplines. The first priority is senior management, followed by appropriate delegates, in case of absence. These include employees having specific regulatory roles or expertise in other disciplines. Attendees include:
- Management Representative
- Person Responsible for Regulatory Compliance (or similar role required by regulations)
- Head of Medical Device Regulatory & Quality (if different to the roles above)
- Chief Executive Officer or Top Management delegates – representing Top Management
- Safety and Risk Management
- Infrastructure (including IT)
- Manufacturing Operations
- Supplier Management
- Clinical Validation and Governance
- Service Support
- Human Resources
Subject Matter Experts do not need to attend Quality Management Reviews for medical devices every time or be present for the full meeting (although it is recommended for awareness). However, mandatory attendance should be clearly defined in the company procedures. Meetings should quorate when mandatory attendees are present, including specified regulatory roles and Top Management. It is also expected that the majority of the data and information is presented by the team harboring the corresponding responsibility.
Quality Management Review Reporting
In the case of ISO audits and agency inspections, it is required to have documented evidence of the management review meetings. The reality is that all auditable activities need to be documented. If they are not, they will not be recognized as completed by the assessor. Audits and inspections involve the validation of controlled and approved (via signature) documents.
While the FDA does not require medical device organizations to share the full minutes of management review meetings, this is not the case with ISO audits. However, it is a minimum requirement to provide meeting dates, the topics covered in each meeting, and the list of attendees.
However, it is also critical to be aware of the record retention requirements for Management Review quality records. Such records should be readily available in case of an inspection/ audit and meet appropriate record retention requirements of regulations the business claims compliance with.
Conclusion: Quality Management Reviews
It is important for businesses in the medical device industry to establish a compliant QMS. This is especially true for companies involved in one or more stages of the product lifecycle. This includes design and development, production, storage and distribution, installation, servicing, technical support, and so on.
However, it is imperative that Top Management is actively involved in Quality Management Review meetings and sets an example for the remainder of the organization. Everyone in the company should engage with QMS processes applicable to them, and utilize the tools and information produced appropriately.
The purpose of the QMS is to ensure the Quality of an organization’s products, services, and operations. Quality Management Reviews are an efficient method to ensure the organization’s quality objectives are met in a systematic, interactive, and data-driven manner. Finally, the established processes must tackle issues, manage changes, and drive improvements starting from the top.
- Medical Device Single Audit Program (MDSAP) MDSAP Audit Model (fda.gov)
- The ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
Published on: April 5, 2023