ISO 13485 is a globally accepted standard for Quality Management Systems (QMS) for the medical device industry. It defines specifications for a quality management system where a company has to show the ability to provide medical products and that relevant services adequately fulfill customer needs and relevant compliance standards. It is designed and intended to be used by organisations for the design and development, manufacture, delivery, repair, and selling of medical devices.
How would we help you attain this QMS for Medical devices?
With the 5 steps approach, the organization can attain the certification in the fastest and most effective way.
- Demonstrate compliance with regulatory and legal requirements
- Manage risk effectively
- Improve processes and efficiencies as necessary
- Gain a competitive advantage
- Become more effective in meeting the customer’s requirements, which helps to instill confidence in the organization, in turn leading to more customers, more sales, and more repeat business
- Ensure compliance with regulations and provision of products and services in the most cost- and resource-efficient manner, creating room for expansion, growth, and profit