When choosing a CDMO for your medical devices, certain things just mustn’t be compromised. Quality is one of them. Having a quality mindset means focusing on patient safety, product quality, and compliance.
The importance of reliable and safe medical devices
Medical devices are fundamental components of health systems. Each day, millions of people rely on them to improve their health and quality of life. They are essential to preventing, diagnosing, treating, and rehabilitating illnesses and diseases safely and effectively. The steps of medical device manufacturing are complex but essential to guarantee their quality, safety, and compatibility with the settings in which they are used.
Consequences of defective medical devices
Defective medical devices can cause discomfort, pain, and suffering for patients. But they can also lead to more severe injury and even death. In fact, every year, the US Food & Drug Administration (FDA) receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries, and malfunctions.
Medical devices range from simple, low-risk devices to complex, high-risk devices. The risks are especially critical for devices that transfer energy or pharmaceuticals to patients, like infusion pumps, or support or sustain vital functions, such as pacemakers.
Regulations in the medtech industry
It goes without saying that a controlled way of manufacturing medical devices is a must to ensure product quality and patient safety. These regulations exist to give not only patients access to high-quality, safe, and effective medical devices but also restrict access to devices that are unsafe or have limited clinical use. Consequently, the medtech industry is subject to a number of regulations.
- The Quality System Regulation (QSR) provided by the FDA is a framework for good medical device manufacturing practice. It includes requirements for manufacturers to establish a quality system appropriate to the devices designed and manufactured and the manufacturing processes employed.
- The Medical Device Regulation (MDR) is a set of regulations for medical devices sold in the EU. It includes standardized technical requirements, testing, and certification procedures for medical devices.
- ISO 13485 is a parallel standard that complements the MDR. It includes requirements for a comprehensive quality management system to design and manufacture medical devices.
Elos Medtech never compromises on quality
At Elos Medtech, our promise is never to compromise on quality. We have worked hard from the very beginning to become best-in-class in regulatory and quality compliance. Over the years, we have established quality management processes and documentation procedures to ensure compliance with adequate regulatory requirements.
We work with a quality mindset every day and are fully committed to:
- Focusing on patient safety in decisions and work processes.
- Ensuring high product quality through dedication to critical details.
- Knowing and following all relevant laws, rules, regulations, and procedures.
Are you looking for a medical device CDMO with a quality mindset? Visit our website today to learn more about how we work with – what we call – Quality Excellence.