Archive of ISO 13485-related posts.

The amendments incorporate by reference (and so align more closely with) the international standard ISO 13485:2016, Medical Devices – Quality Management Systems – Requirements for regulatory purposes. ISO 13485 Certification has the potential to greatly benefit financially all businesses involved in the Medical Device Supply Chain. While ISO 13485 certification is currently not a requirement in...

QMSR & ISO 13485: On 02-Feb-26, the FDA Final Rule comes into force.  The amendments incorporate by reference (and so align more closely with) the international standard ISO 13485:2016, Medical Devices – Quality Management Systems – Requirements for regulatory purposes.  Managing residual risk and understanding risk tolerance are crucial aspects of ISO 13485 compliance. ISO 13485:2016 is...

The proposed EU MDR changes for Software as a Medical Device (SaMD) will be revolutionary. And will be a relief for SMEs, University spin-offs, and Start-Ups, for whom a 6-figure buy-in for Notified Body services has been an insurmountable barrier. Currently, Europe-based developers of SaMD and those in other locations are avoiding the EU market and...

Could you make a successful career in Medical Device Management Consulting? What ISO 13485 training is needed? Dr John FitzGerald writes … “Having worked for 28 years as a management system consultant, I’ve learned a lesson or two (including some bitter ones) on setting up and running a successful management consultancy business. So I’d like to...

  QMSR & ISO 13485: On 02-Feb-26, the FDA Final Rule comes into force.  The amendments incorporate by reference (and so align more closely with) the international standard ISO 13485:2016, Medical Devices – Quality Management Systems – Requirements for regulatory purposes.  There are 139 (sic) instances in ISO 13485:2016 Standard where documentation is mentioned. In developing your...

While ISO 13485:2016 does not contain a formal Context of the Organization (COTO) clause like Annex SL-based standards such as ISO 9001:2015, context-related issues still need to be addressed in practice.  In ISO 13485 (the standard for Medical Device Management Systems), Context of the Organization (COTO) shapes how medical device processes, responsibilities, and controls align...