Capability is often the real bottleneck. When R&D, quality, regulatory, clinical, and operations share a common understanding, there is less rework and smoother reviews. We run practical courses that use your own artifacts and tools, so learning turns straight into better documents, tests and submissions.

→ Standard Training

Focused introductions and refreshers on key standards and regulations, with what reviewers look for and how to apply requirements in day-to-day work. Topics include ISO 9001, ISO 13485, ISO 14971, ISO 45001, ISO 27001, ISO 14001, ISO 19011, MDR/IVDR and FDA pathways.

→ Process Training

Workshops on QMS processes using your real cases to improve speed, consistency, and traceability. Typical areas include document control, design controls and traceability, risk management in practice, supplier quality, production and process control, post-market surveillance, CAPA, change management, and training/competence.

→ Trailer Mode Training 

When you need targeted capability, we design programs around your device, claims, and gaps. Training is paired with real deliverables such as a draft risk file, a verification and validation plan, an audit preparation pack, or submission sections ready to integrate into your process. Sessions can be onsite or remote and are scheduled to fit development milestones.

→ Role-Based Onboarding

New team members often struggle to apply requirements consistently, creating variability and rework. We provide structured onboarding programs tailored to roles such as R&D, QA/RA, clinical, operations and management, ensuring expectations, responsibilities and interfaces are clear from the start.

→ Audit Readiness

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