Regulatory & quality training
Build lasting in-house capability
Practical training for regulatory, quality, clinical and engineering teams, delivered by specialists who apply these requirements on live files every day.
Course areas
What we teach
Regulations
EU MDR and IVDR
- Classification and conformity routes
- Technical documentation and GSPR
- Clinical and performance evaluation
- PMS, vigilance and PSUR
Quality systems
ISO 13485 and FDA QMSR
- QMS requirements and the QMSR transition
- Internal auditing and audit hosting
- CAPA and complaint handling
- MDSAP expectations
Risk
Risk management
- ISO 14971 and ISO/TR 24971
- Hazard analysis, DFMEA and PFMEA
- Benefit–risk and the risk management report
Software
Software, AI and cybersecurity
- IEC 62304 software lifecycle
- Cybersecurity per IEC 81001-5-1
- AI/ML devices, PCCPs and Good Machine Learning Practice
Clinical & post-market
Evidence and surveillance
- Literature review methodology
- Writing CERs and PERs reviewers accept
- PMCF and PMPF design
- Reportability decisions
Foundations
PRRC and regulatory foundations
- PRRC responsibilities under Article 15
- Regulatory basics for new RA and QA staff
- Mentoring through live technical files
Formats
Delivered the way your team learns
In-company workshops
On-site sessions built around your products and procedures.
Virtual instructor-led
Live online sessions for teams across sites and time zones.
LMS modules
Self-paced modules for onboarding and refresher training.
Train-the-trainer
Equip your internal trainers to cascade the programme.
How it works
From needs to competency records
- 01Needs assessmentRoles, current competence and upcoming audits or submissions.
- 02Tailored curriculumContent built around your devices, markets and procedures.
- 03DeliveryWorkshops, virtual sessions or modules, with practical exercises.
- 04RecordsAttendance and assessment records ready for your QMS training files.
Talk to our experts
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.