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 […]

ISO 27001 offers a comprehensive framework that can incorporate all information security regulations and schemes – GDPR, HIPAA, SOC 2, CCPA, etc. Information security/cybersecurity has become crucial to any organization’s functioning in today’s digital age. With the increasing amount of data and sensitive information being stored and transmitted through various digital channels, organizations need to […]

Recommended as part of ISO 27001 Training or on Day 1 of Induction Training for new recruits A cyberattack can destroy a business. Whether that involves Denial-of-Service attacks, file deletion, ransomware, or other cyberattacks, the most common factor they share is human failure. Currently, the most common human failure is falling victim to a Phishing e-mail, which has […]

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 […]

When a certificate does not show an ISO 17025 Accreditation logo, a Calibration Certificate can be difficult to check. And sometimes it’s as if the Calibration Laboratory were trying to confuse you! ISO 17025:2017, which sets out general requirements for the competence of testing and calibration laboratories, has in recent years become the ‘new normal’ for laboratories offering […]

  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 […]

Compliance with Context of the Organization (COTO) requirements for ISO 45001 differs significantly from that for ISO 9001 COTO requirements. Don’t get caught out. Many modern ISO management system standards include a Context of the Organization (COTO) clause, and the core principle remains mostly consistent across standards. That said, similar clauses do not always translate into […]