deGRANDSON Global Blog

News and Commentary on ISO Management System Standards

19 Feb 2026

Most SaMD to be reclassified as MDR Class 1

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 initially launching their products in the USA ...

20 Jan 2026

ISO 13485 Risk Evaluation in Medical Devices explained

ISO 13485

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. Two distinct and different requirements in ISO 13485:2016 for the management of risk. From Dr John FitzGerald: Misinformation ...

16 Dec 2025

Cybersecurity for Medical Devices

ISO 13485, ISO 27001

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. Did you know that cybersecurity is addressed in ISO 13485:2016, Clause 7.3? Whether you are marketing a Medical Device ...

25 Sep 2025

FDA QMSR and ISO 13485 – what you need to know

ISO 13485

On 02-Feb-26, the FDA Final Rule, amending the Current Good Manufacturing Practice (cGMP) requirement of the Quality System Regulation (QSR) of medical device manufacture, 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. The new ...

16 Sep 2025

Preparing for your first ISO 13485 Certification Audit

ISO 13485

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. Your old ISO 9001 QMS 'dolled up' with the language of the 2016 Standard is not going to be adequate. When you are first ...

02 Sep 2025

ISO 13485 What New Suppliers to the Medical Device Sector Need to Know

ISO 13485

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. Great opportunities for Suppliers to the Medical Device Sectors on both sides of the Atlantic. In February 2026, the FDA ...

17 Jul 2025

ISO 13485, a global requirement in Medical Device Regulations

ISO 13485

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. ISO 13485 Certification has the potential to greatly benefit financially all businesses involved in the Medical Device Supply ...

10 Jul 2025

ISO 13485: Critical Subcontractors and Crucial Suppliers

ISO 13485

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. Suppliers to the Medical Device Sector can get surprise visits too! EU Regulations, EN Standards, Notified Body activities ...

29 Apr 2025

Unannounced Audits by Notified Bodies: What you need to Know

ISO 13485

If your company supplies components or materials to an EU medical device manufacturer, here is the information you need to be aware of, as outlined in the ISO 13485 Regulations. And it's about unannounced audits of your business by Notified Bodies.

22 Apr 2025

The IAF Logo on your ISO 13485 Certificate?

ISO 13485

The IAF MLA mark is now available to all CABs accredited by The European Cooperation for Accreditation (EA) Members and is recognized and accepted by all 563 IAF members from 81 countries.