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.
ISO 13485 is the best internationally accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. ISO 13485 is the QMS standard accepted as the basis for CE marking medical devices under European Directives and Regulations and UKCA marking medical devices under the UK MDR 2002. ISO 13485:2016 remains a state-of-the-art document.
BSI, as one of the leading EU notified bodies and UK approved bodies, can verify medical device manufacturers’ selection of the most efficient conformity assessment routes to achieve CE and UKCA marking.