Training & Capability Development
Upskill your organisation. Practical training delivered by practitioners, tailored to engineering, quality and leadership teams developing regulated software.
Organisations we support.
- Engineering teams new to developing software under IEC 62304.
- QA and RA functions supporting software-based products for the first time.
- Product managers who need to understand regulatory constraints on the roadmap.
- Leadership teams accountable for regulated software outcomes.
What typically goes wrong.
- Standards understood in theory but not in day-to-day engineering practice.
- Quality and engineering teams working from different vocabularies.
- Generic off-the-shelf courses that don't map to how your team actually builds.
- Knowledge concentrated in one or two people, leaving the organisation exposed.
The work we perform.
Tailored curricula
Content shaped around your product, classification, tooling and existing processes.
Engineering training
Applying IEC 62304, traceability and V&V in real development workflows.
QA & RA training
Software-specific evidence expectations for quality and regulatory functions.
Product & leadership sessions
What regulation means for roadmap, release cadence and governance decisions.
Delivery formats
On-site, remote or hybrid; single sessions, series or embedded coaching.
Workshops
Hands-on working sessions applied directly to your own documentation and code.
What you might receive.
Scope is agreed per engagement — the outputs below are typical examples.
Training is delivered by the same practitioners who build and submit regulated software. Examples come from real engagements rather than textbooks, so teams leave able to apply the standard to their own product on Monday morning. Example topics include the regulatory landscape, IEC 62304, ISO 14971, SOUP/OSS/SBOM and post-market software maintenance.
Build capability in-house.
Tell us who needs training and what they're working on, and we'll shape a programme.