About This Course
This course is written and maintained by St John Lynch & Co Ltd. A consultancy that works in medical device software (SaMD, SiMD, Health Software and AI-enabled Health Software).
Technical qualifications
This course provides formal grounding in the standards this course teaches. The author is a member of the IEC 62304 committee and other standards necessary for medical device software development including AI-enabled Health Software.
ISO 13485
Auditing and training in the quality management system standard IEC 62304 §4.1 requires every software lifecycle process to sit inside — the QMS this whole course assumes is already in place.
ISO 27001
Auditing and training in information security management — increasingly relevant to medical device software as connected devices and cloud-backed services widen the attack surface a manufacturer has to account for.
IEC 81001-5-1
Auditing and training in health software security — the standard that intersects most directly with IEC 62304's own Amendment 1 cybersecurity additions covered throughout this course.
Experiential qualifications
Standards knowledge answers "what does the clause require?" Experience answers the harder question this course spends most of its time on: what does that actually look like in a real project?
Software development for SaMD & health software
Hands-on development of Software as a Medical Device, AI-enabled devices, and health software more broadly — the practitioner's side of IEC 62304, not only the assessor's side.
Regulatory strategy to market support
Experience carrying a regulatory strategy through to an actual market submission — the difference between knowing what a clause requires and knowing what a notified body or FDA reviewer actually pushes back on.
ISO & IEC audits, conducted
Direct audit experience against ISO 13485, ISO 27001 and IEC 81001-5-1 — seeing first-hand what evidence actually satisfies an auditor, and what looks complete on paper but does not.
The proof: this site practices what it teaches
This course's software development tool practices IEC 62304 development even when developing non-medical devices, because there is more learning in the doing. This ensures our staff have indepth understanding of IEC 62304 intricacies.
Work with St John Lynch & Co
The organisation behind this course delivers medical device software and services for start-up, SME, and multinational organisations, including software and AI development, regulatory strategy, change assessments and auditing to name a few services.