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March 21, 2016

The ISO 13485 is updated, what is next?

Learn more about how the ISO 13485 relates to the CE Marking process

The display of a CE-mark on a medical device implies that the device meets all applicable conformity requirements of European Directive 93/42/EEC. The CE mark process itself is described here in more detail.

In order to demonstrate conformity with the Medical Device Directive, it is essential to have a Quality Management System (QMS) in place that meets high standards. ISO 13485 ‘Medical Devices – Quality Management Systems – Requirements for regulatory purposes’ has been adopted by the European Committee as a standard QMS for medical device manufacturers. On the 1st of March 2016, the International Standards Organization published an update to this standard, referred to as ISO 13485:2016. So this is the perfect time to take a closer look at one of the main changes of this renewed ISO: the focus on QMS of outsourced processes.

ISO 13485:2016 puts more focus on the role of the QMS throughout the entire development process of the medical devices, including outsourced development activities. One can easily interpret that manufacturers of medical devices are now even stronger advised to select suppliers that are ISO 13485 certified to ensure conformity with the requirements of the Medical Device Directive. This increased focus on QMSs for suppliers in ISO 13485 is not surprising. Today’s wide variety in options of critical suppliers makes one realize that outsourcing of processes is associated with increased risks. These risks should be managed and assessed in an appropriate manner.

Technology and medical devices companies are constantly driving the fast lane. As a result, the international standards and regulation evolve rapidly in order to provide an appropriate and suitable regulatory framework. ISO 13485 is updated to harmonize with global regulatory requirements. Make sure you are ready to keep up with the changing medical device environment; Start Sooner Finish Faster.

Recommendation: One of the requirements of the Medical Device Directive is the provision of clinical data. Many clinical studies that serve the goal of gathering clinical (safety and efficacy) data are outsourced. Selection of the right qualified supplier can make the difference.

By Alwin van den Broek

About the author


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