We help medical software manufacturers develop ISO 13485 compliant Quality Management Systems (QMS) that meet the rigorous standards required for medical devices and related services. The ISO 13485 standard is the accepted standard for EU MDR and FDA compliance and is essential for ensuring product safety and customer satisfaction. Our team of expert consultants will guide your organization in developing and implementing ISO 13485 compliant QMS for medical software products.
Our experience working with medtech software products has shown that many companies implement a QMS that is designed for manufacturing medical hardware products. However, medical software has unique QMS needs and requires a different approach. A QMS designed for software should be lightweight and allow for agile design and development of your application.
We work closely with your team to understand your organization's goals, processes, and workflows, and identify any areas of improvement. Our consultants will guide you through each step of the development process, from defining your quality policy to creating a comprehensive Quality Manual that includes all the necessary procedures, work instructions, and forms required for compliance.
We rely on real-world experience and industry best practices to design and implement QMS for medical software. We will help you navigate the complex landscape of regulatory compliance and develop a QMS that meets all the necessary requirements for manufacturing software products that are classified as a medical device. Our expertise will save you time, money, and resources, and give you the confidence that your QMS is optimized for success.
Contact us today to learn more about our QMS development services.
