Medical device companies often have to adhere to strict standards in order to operate. These standards help ensure safety and quality control for both the company and its customers. One of the most important tools used by medical device companies is a Quality Management System (QMS).
What is a quality management system (QMS)?
A Quality Management System (QMS) is a solution designed to achieve quality policies and objectives by documenting responsibilities, procedures, and processes. A digital quality management system can be used to directly coordinate a company’s organizational activities and better meet customer and regulatory demands.
QMS offers a vast array of benefits to the organizations that adopt them. For instance, the software facilitates meeting quality objectives regarding customer demand. A QMS makes building good relationships with consumers easier and can lead to higher sales numbers.
Another considerable advantage of QMS is being able to meet regulatory requirements with greater ease. The software ensures regulatory compliance while also enabling the achievement of higher product quality. QMS helps organizations operate with the most efficient use of money and resources, creating various opportunities for expansion, growth, and profit.
Other benefits of QMS include the following:
- Reducing waste generated by daily operations
- Redefining, improving, and controlling administrative processes
- Limiting mistakes caused by human error
- Lowering operational costs
- Finding productivity gaps and training opportunities
- Providing insights for quality management
- Empowering staff to do their assignments better and managers to make better decisions
- Helping create an organization-wide direction
- Monitoring workflows to guarantee consistent results
Why is a QMS important for medical devices?
Implementing QMS for medical devices can significantly enhance product quality. Likewise, medical device companies can use QMS to improve their services, meet customer demands, and satisfy regulatory requirements. Medical device manufacturers can use QMS to reduce the market time for new devices. Thanks to the software’s analytical capacities, it is easy to discover the root cause of errors and take corrective action.
Non-value-added and waste activities can also be easily recognized and dealt with. Moreover, the increased operational efficiency translates into better supplier management, improving relationships with trading partners. Most major markets have quality management system requirements for life science companies that wish to bring a product to market. Keeping an international standard of quality is extremely important in the medical device industry.
What are the main regulations governing medical device QMS?
There are two main quality regulations that should be followed by all medical device manufacturers: the ISO 13485:2016 standard and the FDA 21 CFR Part 820 regulations. To comply with these regulations, a company requires constant vigilance. Through the use of automated solutions, it is possible to keep an organization’s compliance in check. Medical device quality management software can be used to enable the best standards for regulatory standard monitoring and certification.
ISO 13485:2016 Standard
The ISO 13485 standard specifies the regulatory requirements for medical device quality management systems. ISO 13485:2016 is the current version of this standard. Through compliance with this standard, companies demonstrate their ability to produce medical devices and related services that meet customer and regulatory demands.
While strict compliance with the standard is not mandatory, regulatory bodies such as the EU MDR ask specifically for a quality management system to be put in place. The requirements of ISO 13485 certify that a company fulfills all quality management system requirements.
The standard is concerned with various stages of the product life cycle, including its design, development, production, storage, distribution, and installation. Additionally, suppliers and other third parties can rely on ISO 13485:2016 to guarantee that good standards have been followed throughout a product’s creation.
FDA 21 CFR Part 820 Regulations
The 21 CFR Part 820 is a component of the Current Good Manufacturing Practice (CGMP) regulations, an FDA quality system regulation strategy. It is used in the US to ensure the satisfactory safety and effectiveness of all medical devices. While proof of compliance with ISO 13485:2016 is voluntary, 21 CFR Part 820 is mandatory. Only FDA-regulated devices can be sold in the US. All medical device manufacturers are subject to its regulations and should expect regular quality audits from the FDA.
What ISO standards apply to medical devices?
The ISO standards that apply to a medical device depend on the specific product features. For instance, a medical device that makes use of a software app will have specific quality standards to fulfill. Manufacturers must determine which ISO standards apply to them.
While ISO standards are not explicit requirements for quality systems, any deviations from the norm should be properly addressed and justified. In case there are deviations, companies must explain how the regulatory purposes of the standard are still achieved.
Some of the main quality standards followed by medical device manufacturers are:
- ISO 13485: Standard for the quality management of medical devices
- ISO 14971: Standard for the risk management of medical devices
- ISO 9001: Standard for business quality management systems
- ISO 62304: Standard for software used in medical devices
- ISO 10993: Standard for the biological evaluation of medical devices
- ISO 15223: Standard for symbols used in the labels of medical devices
- ISO 11135: Standard for the sterilization of medical devices
- ISO 11607: Standard for sterilized product packaging
A step-by-step guide to medical device quality system management
Although both ISO 13485 and 21 CFR Part 820 have similar goals, they are different documents with different approaches to quality system regulation.
According to ISO 13485
- Documentation requirements: These include the possession of a quality manual, medical device file, document control, and control of records. The quality manual should contain the entire scope of the QMS and outline the structure the documentation will follow.
- Management responsibility: The management team must commit to maintaining internal quality standards and creating a suitable quality policy. Procedures must be documented for management review.
- Resource management: Companies must document all the necessary requirements to manufacture the device, including the training and competency of staff. This also encompasses infrastructure, processes, workspaces, equipment, and software used to support business operations.
- Product realization planning: Life science companies must explain how the development, manufacturing, and distribution of medical devices will be handled. It is also important to address the resources and processes used to define client needs and field services.
- Customer-related processes: These are the requirements to meet the needs of the patients, end users, and anyone else who will come into contact with the device. This comprehends regulatory agencies, distributors, and parties involved with purchasing, shipping, and running logistics.
- Design and development processes: All processes for the design and development of new devices must be documented. This includes planning, inputs, outputs, reviews, verification, validation, transfer, and change control.
- Purchasing: During this step, a company must document purchasing processes to ensure the good standing of materials, components, and other products. Companies must explain their criteria for the selection, monitoring, and evaluation of suppliers.
According to 21 CFR Part 820
- Management controls (MC): These are set to establish a quality policy and a reliable organizational structure. The MC must prepare companies for management reviews and quality audits,
- Design controls: Design control requirements are put in place to control the entire design process. Design control procedures include describing design and development activities, validating the design, controlling design changes, and reviewing results. The information must be compiled in a design history file.
- Production and process controls: The entire manufacturing process must be monitored and controlled. Companies must implement statistical techniques to determine the suitability of processes.
- Corrective and preventive action (CAPA): Risk management processes must be standardized and documented. This includes the collection of data, the investigation of product quality, and the methods to undertake corrective and preventive action.
When is a Quality Management System required for medical devices?
Establishing effective medical device quality management systems should be done as soon as a company determines the markets it wishes to enter. Since it may take months to fully institute a proper QMS, it should be done early to save a considerable amount of money, time, and effort.
Before a medical device can be marketed in the US, it must be in compliance with regulations set by the FDA 21 CFR 820. Companies that produce medium to high-risk medical devices must also go through 510(K) processes. The FDA performs random inspections for registered Class I or II medical devices. In most of the EU, companies must obtain CE Marking for medical devices before their distribution. Usually, the necessary device quality management requirements can be fulfilled through compliance with ISO 13485:2016.
Best QMS software for medical devices
Agatha Quality QMS is the ideal QMS software solution for medical device companies. By partnering with Agatha, you’re guaranteed to receive the best QMS software for medical devices. Your entire quality management system will be specifically designed to cater to the needs of the pharmaceutical world.
This pharma, biotech, and medical device QMS software empowers life science companies to accelerate trials, monitor and manage quality processes, and improve clinical study results. Thanks to Agatha Quality QMS, an organization can maximize efficiency and compliance while avoiding delays, added costs, and major disruptions.