What is ISO:13485 certification and why do medical imaging equipment manufacturers need it
The medical device manufacturing sector is highly regulated in order to ensure the safety and efficacy of medical devices. In order to meet these regulatory requirements, manufacturers must have a significant quality management system (QMS) and product requirements in place. Medical imaging equipment manufacturers, for example, are required to design digital x-ray equipment that is safe and fit for its intended purpose. These requirements help to ensure that medical devices are consistently manufactured to a high standard and that they perform as intended when used on patients.
The ISO:13485 standard is an effective solution for meeting the comprehensive requirements for a QMS. Adopting ISO:13485 provides a practical foundation for manufacturers to address the regulations and responsibilities associated with medical devices. It also demonstrates a commitment to the safety and quality of medical devices.
The benefits of ISO:13485 certification for medical imaging equipment distributors
Many medical device manufacturers require their suppliers and service providers to be certified to ISO:13485 in order to do business with them. As a result, certification can enhance an organization’s marketability as a supplier or service provider for medical device manufacturers. For designers, manufacturers, and distributors of medical devices, ISO:13485 certification provides assurance that their products meet the highest quality standards. In addition, certification can help Organizations demonstrate compliance with applicable laws and regulations. As the medical device industry continues to grow and evolve, ISO:13485 certification will become increasingly important for companies operating in this space.
The challenges of achieving an ISO:13485 certification
In order to obtain certification, you must first undergo a rigorous audit by a third-party registrar. This audit will assess your compliance with the relevant standard, and you will need to demonstrate that your entire organization is committed to meeting the requirements.
ISO:13485 is part of Brown’s Medical Imaging’s commitment to quality
At Brown’s Medical Imaging, we are proud to be ISO:13485 certified. Our ISO:13485 certification is the capstone of our commitment to quality and customer service. It involves rigorous testing and periodic audits to ensure our quality management system is functioning effectively. When you partner with Brown’s, you are partnering with our dedication to outstanding quality, dependability, and customer satisfaction.