ISO 13485 Quality Management System

If you are a medical device manufacturer wishing to sell your products across multiple global markets, an MDSAP audit can help you minimise disruption from multiple audits and meet regulatory requirements.

ISO 13485 is important to designers, manufacturers, and distributors of medical devices. In addition, suppliers and service providers can enhance an organization's marketability as more and more manufacturers require certification in order to do business with a vendor.

When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products, and ensuring effectiveness, control and maintenance of your QMS is critical to customers, stakeholders, patients and users, and regulatory agencies.

The value of ISO 13485 is not just in the implementation, but also in providing a tool for a thorough audit to test the effectiveness of the system. It provides the manufacturer with a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements. It can also help to minimize surprises and failures which might adversely affect patient safety and damage a manufacturer's reputation.