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How Medical Device Factories Ensure Safety

In the field of healthcare, the ones in the frontlines are who we often get to see. What we mostly don’t know is that there are those working behind the scenes to create and deliver the needed medical devices and equipment. Factories, manufacturers, and developers of medical devices are the underappreciated members of the healthcare field in their constant and consistent role of ensuring that medical professionals and patients get to use safe and effective devices for their medical needs. Some of us may have wondered where and how the medical devices we see are made.

Luckily, we’re about to find out here as we discuss how medical device factories ensure safety.

Blood glucose test set

Quality and Safety Standards Compliance

Medical device factories and manufacturers make it a point to regularly undergo audits and comply with the updated standards of the relevant regulating bodies of their region and of the regions where they export their medical devices. Thus, it would be no surprise if such specialized factories would undergo audits and inspections from ISO 13485, ISO 14971, or both. The former is a quality management system standard for organizations and establishments involved with the design and manufacturing of medical devices. The latter is a standard for the identification, monitoring, and control of risks and hazards associated with medical devices. You’ll know that your medical devices are of high quality and safe to use if you see these certifications in the company or manufacturer’s profile.

Clinical Research-Backed Production

Many regulatory bodies in the US and Europe have implemented the requirement of having clinical data to support the device safety claims and projections of companies who produce or manufacture medical instruments and devices. Many reputable and established medical device manufacturers take the effort of partnering with third-party clinical research organizations to meet the regulatory requirements and to further improve the quality and safety of their production process. This practice ensures the business continuity of the manufacturers and enhances their ability to adjust the product specifications according to research data. 

Human Factor Engineering and Design

The roles of medical device manufacturers don’t just end with the creation of the finished product and delivering them to the distributors. They have the responsibility of creating comprehensive user manuals on how to properly operate or use the devices and avoid accidents and dangers associated with human operation error. Some companies and manufacturers also incorporate failsafe mechanisms to further ensure the safety of their products and that they calculated the risks of human errors in their design. Others incorporate ergonomic, and functionality features in their products, where handles are easy to grip, or the basic and useful functions are all found in the buttons and switches of the device.

Rigorous Security Measures

The security measures implemented in medical device factories do not just involve the protection and safekeeping of the device from damage, theft, and loss. Due to the latest technological developments, some of these devices have the capability to connect with information systems and the internet. The integration of AI, VR, and AR technology has prompted the need to have cybersecurity measures in place at the manufacturer level. Thus, regulatory bodies such as the FDA have added the security requirement of meeting the UL 2900-1 and UL 2900-2-1 standards when it comes to network-connectable medical devices for the monitoring and control of possible security risks and vulnerabilities. Thus, patients and doctors can be assured that no data collected and stored through these devices are leaked or inappropriately used outside of the medical institutions.

medical monitor

The safety and wellness we are enjoying from the medical devices we use or utilize in hospitals and clinics are made possible through the diligent efforts of device manufacturers. In the healthcare field, these manufacturers are the unseen hands that help push medical and healthcare progress forward. It is reassuring to know that manufacturers are undergoing rigorous quality, safety, monitoring, and regulatory standards to ensure the safety of their devices. We hope that the knowledge we gained can help us appreciate medical device factories and manufacturers more.

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