deGRANDSON Global Blog

News and Commentary on ISO Management System Standards

12 May 2026

ISO 13485 Consultancy: Be a successful MDMS Consultant

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 share my experience with you in this article. This ...

30 Apr 2026

FDA QMSR and ISO 14971: What to do about Risk Management

ISO 13485, ISO 14971

Don't believe everything you read about ISO 14971! The FDA's 'Medical Devices; Quality System Regulation Amendments' website explicitly states: All sections of ISO 13485 apply to device manufacturers. While there is much mention of 'incorporating by reference' and many misguided interpretations of that phrase, don't let anyone mislead you. To reiterate, the FDA's website explicitly states that ...

07 Apr 2026

Medical Devices: Residual Risk and Risk Tolerance

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. Managing residual risk and understanding risk tolerance are crucial aspects of ISO 13485 compliance. ISO 13485:2016 is an ...

19 Feb 2026

Most SaMD to be reclassified as MDR Class 1

ISO 13485

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 ...