The medical devices and IVD industry is about to see the world’s most popular ISO standard for medical devices & IVDs quality management systems (QMS) revised significantly. James Alexander, Procorre, explains how device manufacturers can prepare for the changes and gives practical steps on becoming fully compliant.

There are many steps a business must take to ensure each product is fully compliant, including:

  1. An initial gap analysis to challenge their products’ lifecycle(s) – this should take between two to three full days
  2. Thoroughly review the gap analysis report to identify any major and minor non-conformances
  3. Produce a complete project plan (using a Gantt chart for example) driven by the gap analysis and based on the business’s preferred timeline to get fully compliant QMS and technical files in place
  4. Develop the QMS and technical files and deliver the project – this should take approximately 10 to 15 days of consulting support, depending on the size of the business and the classification level and number of products being audited
  5. Roll out the processes with internal staff (i.e. implementation phase) and then introduce an independent lead auditor to do a pre-assessment and identify any corrective action needed
  6. Arrange for a third-party auditing organisation (i.e. a notified body such as SGS, Lloyds, BSI etc.) to perform a certification assessment. Upon completion, you’ll be awarded the new ISO 13485:2016 and CE mark approval certifications.

If a business is considering bringing in a specialist team of device subcontractors, they may also decide to continue that relationship on an ‘outsourcing’ basis, to keep their QMS updated and manage potential complaints and/or reportable adverse incidents.

The transition periods seem to give plenty of time to introduce the necessary changes, however the extent and complexity of the changes are significant, and it is expected to take between six and 18 months to fully upgrade the QMS and technical construction files, so we’re urging organisations to start the process as soon as possible to avoid having their devices removed from the EU market.

To find out more about the ISO13485:2016 standard, and the ‘Recast MDR and IVDR regulations, download our medical devices whitepaper:

Lookout for Part 1 of the post where we look at some of the steps a business must take to ensure each product is fully compliant.