Medical devices have been clinically proven to save thousands of lives on an annual basis. There is no doubt that medical device quality plays a key role in these life-saving measures. Quality assurance in medical devices is of the utmost importance to promote the utilization of high-quality products.
Device quality assurance, however, is not the only component of the quality process. Quality control of medical devices is equally as important as quality assurance (QA) in medical device manufacturing. Defective products can prove quite costly for the medical device industry and can also cause risk to patients.
In 2018, more than 441 million devices were recalled, most commonly due to software issues. As a result, trends show there will be greater emphasis placed on the software utilized in medical devices.
Quality assurance and quality control are integral to the quality management system (QMS) in the medical device industry. Failure to recognize the distinct nature of these quality functions will result in dangerous products.
Product development failures are not an option for a medical device company. The design process and product development must adhere to the medical device regulations the FDA requires.
Regulatory requirements must be met during the manufacturing process to prevent and eradicate defective products.
Quality Assurance in Medical Devices
Quality assurance in medical devices is centered around the prevention of flaws during the manufacturing process. As part of the quality assurance process, manufacturing processes are evaluated to determine problem areas that may result in defective products.
Quality assurance in the medical device industry is highly process-focused. Quality assurance staff have many tools available to assist them with testing efforts.
Quality Assurance Tasks
Routine Audits: The quality assurance team will evaluate the manufacturing process to confirm medical devices regulations and FDA requirements are met.
Process Logistics: The quality assurance team will identify each process and how the process works.
Equipment Selection: The quality assurance team will choose new manufacturing equipment and test the equipment currently in use.
Training and Development: The quality assurance team will provide ongoing training to staff to ensure they are equipped to handle their assignments in the process.
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Quality Control of Medical Devices
Quality control of medical devices is focused on detecting flaws that are present following manufacturing prior to distribution. Products are tested for quality control to identify and isolate any defective products before they reach the distribution phase.
Quality control of medical devices prevents defective medical devices from being distributed for public use. This is an extremely important control function. Quality control prevents end users from being exposed to risks associated with medical devices that do not conform to product specifications.
Common Control Tactics
- Acceptance Criteria: The FDA requires quality control staff to create a formal document that provides an in-depth explanation of how they will determine whether the products conform to product specifications. Documentation and tracking of conforming and nonconforming products are required.
- Product Testing: Product testing requires a detailed account of how the quality control staff determines whether a product is ready for distribution. Documentation evidencing the effectiveness of the methods used to inspect, test, and verify conformity is required.
- Corrective and Prevention Action (CAPA) Management: This involves using an investigative management system that identifies a defective or nonconforming product, conducting a root-cause analysis, and uncovering a systemic process flaw.
Differences Between Quality Assurance and Quality Control
Here is a quick breakdown of the key differences between quality control and quality assurance of medical devices.
| Quality Assurance | Quality Control |
| Quality assurance is process driven | Quality control is product driven |
| Proactive emphasis on preventing the manufacturing of nonconforming products | Reactive approach to capture deficient products that have been manufactured |
| The end goal is to eliminate systemic imperfections in the manufacturing process | The end goal is to ensure products are free of imperfection prior to distribution |
| Focuses on preventing defects | Focuses on identifying defects |
Quality assurance and quality control work towards achieving a shared goal. Both aim to ensure the resulting medical device is of high quality and safe for the end user. However, quality assurance and quality control perform different functions for the medical device company.
Quality Management System (QMS) Software
ISO 13485:2016 provides specific requirements for quality management systems. A medical device company must demonstrate its ability to consistently produce medical devices that meet regulatory requirements.
It is important for medical device companies to secure the latest and best QMS software available. The right QMS software will provide you with document management, supplier controls, and easy access to product specifications.
Since the QMS you employ directly affects your ability to conduct quality assurance and quality control audits, choosing the best QMS software for your business is key.
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Choosing the Right Fit for Your Medical Device Projects
The medical device industry has exceedingly high standards for quality assurance and quality control for medical devices. When it comes to the quality and safety of your product, you cannot afford to take the risk of shipping nonconforming products to end users.
Mitigate the risk of releasing defective products and partner with RBC Medical, a leading medical device manufacturing company with over 25 years of experience.
Take the guesswork out of quality assurance and quality control of medical devices, and see why more than 93% of our clients return to us for additional projects. Contact us today for more information.
