No headache for your ISO 13485 compliance

With the publication of the new  ISO 13485:2016 standard regarding quality management systems for medical devices in March 2016 the old 2003 or 2015 version of the standard will be recalled. The transition period has begun in March 2016  and the new  ISO 13485:2016 standard regarding quality management systems for medical devices will be in force in March 2019.

Does your QMS needs updating or are you dealing with an older  version of the ISO 13485 standard?

If your company has implemented the 2003 or 2015 version of the ISO 13485 standard a critical review of your present quality management system should take place. To update your present system, it is required to review the current system and implement the requirements of the new 2016 version. Let our experts help you out with this time consuming process and arrange your necessary compliance.

Don’t hesitate, act as soon as possible.

Baseline procedure and GAP analysis

CE Medical has developed a “baseline procedure” in combination with our GAP analysis to analyze your present quality management system. This procedure allows us to clearly indicate what must be modified to comply with the new ISO 13485: 2016.

This “baseline procedure”  is custom made for your company and its products.

Practical hands on support

Our quality assurance experts offer full support in the following situations:

• Updating the present system
• Carrying out pre-audits
• Preparing for notified body audit.

Our experts work closely with several notified bodies to ensure a smooth transition and conformation.

As time is limited don’t hesitate; contact us for your ISO 13485:2016 Quality Management System