Compliance with safety and quality standards is a high priority for any manufacturing organization, but it's especially important for medical device manufacturers. Patient safety is on the line, and manufacturers face significant requirements imposed by the U.S. Food and Drug Administration (FDA) and similar bodies worldwide. Non-compliance and consumer lawsuits lead to manufacturers losing millions of dollars. That's why quality and safety are among the top challenges for medical device manufacturers.
To help meet the high standards set by patients, medical professionals, and government regulators, manufacturers implement a quality management system (QMS) compliant with the ISO 13485 standard. However, getting started with a QMS presents challenges of its own. Here's what you need to know about medical device manufacturing and quality management systems — and how to get it right.
A quality management system is a standardized framework of policies, processes, and procedures to help business operations meet specific benchmarks.
Adhering to a QMS's standards signals customers that the company takes safety and product quality seriously. An effective QMS provides a framework for continuous improvement and risk management to ensure ongoing high standards for safety and efficacy. Periodic audits against the standard ensure ongoing compliance.
In the world of medical devices, a QMS guides manufacturers in designing, developing, manufacturing, and distributing products. It ensures that a medical device manufacturer consistently meets rigorous FDA regulatory standards, customer expectations, and delivers safe devices.
While every medical manufacturer can develop a QMS tailored to its specific operations and market, each strives to comply with ISO 13485, the global benchmark for medical device quality systems.
Adherence to ISO 13485 facilitates market access globally and demonstrates a commitment to quality. Key components of the standard include:
Read: FDA Compliance and Audits in Medical Device Contract Manufacturing
A robust QMS is the key to meeting the requirements mandated by the FDA, the European Union, and other regulatory bodies. Compliance with ISO 13485 provides a foundation for regulatory approval of your devices. That's because regulators recognize that an ISO 13485-compliant QMS takes patient safety seriously by proactively minimizing the risk of errors, failures, and malfunctions.
Internally, a QMS drives manufacturing organizations toward high product quality and reliability standards. Thanks to the high standards set by the QMS, physicians and patients can be confident that your devices will work as intended every time. That trust extends to the global market, enhancing your company's reputation in the industry.
For all its benefits, implementing and maintaining an ISO 13485-compliant QMS can prove challenging for medical device manufacturers. The first major hurdle is often resource allocation. Developing a system that's compliant with this standard requires considerable investment in time, specialized personnel, and resources.
ISO 13485 is known for its stringent documentation and record-keeping requirements, which can be time-consuming and burdensome for internal teams. Successfully instilling a quality-focused mindset across the entire organization requires substantial effort and effective change management strategies.
After implementation, staying updated on evolving regulations requires a dedicated quality systems team and making adjustments as necessary. Given all these challenges, it's no wonder that businesses in the medical device industry look for alternatives that relieve some of the hurdles of ISO 13485 compliance.
Partnering with a contract manufacturer with proven medical device experience and expertise in ISO is the best solution. Selecting the right medical device contract manufacturer can give your company a strategic advantage, as it allows you to spend more time on design and innovation and less on ISO compliance.
By using the contract manufacturer's established and certified system, device manufacturers can significantly reduce the time, resources, and complexity involved. The best contract manufacturers are highly knowledgeable about the intricate requirements of the medical device industry and have already reached ISO 13485 compliance, saving your organization valuable time.
Outsourcing accelerates the entire development process, including testing and regulatory clearance, and leads to faster time-to-market. This partnership also allows companies to focus their internal resources on their core strengths, such as product innovation, research, and market development. Plus, contract manufacturers benefit from economies of scale, which translates into cost savings for their clients. That includes your investment in a QMS, specialized facilities, and quality systems personnel.
Read: Top Reasons OEMs Choose to Outsource Medical Device Manufacturing
When it comes to electronic medical devices, a meticulous QMS is more than just a good practice — it's a necessity. Implementing and maintaining a QMS compliant with ISO 13485 can significantly drain resources. But when you choose Sanbor Medical as your medical device contract manufacturer, you immediately gain a partner experienced with the highest quality standards.
Our team of manufacturing professionals is dedicated to streamlining your production process, optimizing costs, and ensuring compliance with global standards. To learn how our medical device contract manufacturing services can help you achieve significant cost savings, contact Sanbor Medical today.
