Our courses start from what we see in the field: the recurring gaps during notified body audits, the pitfalls of the MDR technical file, the sticking points of clinical evaluation. We train quality managers, regulatory affairs officers, design engineers, PRRCs and executives. In person, in-house or via e-learning.
For whom
Teams building up their skills together. 1 to 3 days, in person or in a virtual classroom, delivered by Thomas Trullen or Jonathan Bedin.
Choose this format when
You are preparing an ISO 13485 certification, you are integrating the MDR on a new product, you are restructuring your QMS after an audit finding.
Format
Inter: scheduled sessions, up to 8 participants. Intra: date and location at your convenience, from 3 participants.
For whom
Self-directed staff or distributed teams. Short modules, validation quizzes, accessible 24/7 from any device.
Choose this format when
Onboarding a new employee, occasional upskilling, continuous training without scheduling constraints.
Format
Access within 48 hours of ordering. Content updated with every significant regulatory change.
What stays the same, whatever the format
Real cases
In-house: work on your documents, under NDA. Inter: practical cases drawn from anonymised field situations, not fictional case studies.
Content authors
The same consultants in active assignments. No trainers disconnected from the field.
Post-training support
30-day hotline included for the operational questions that arise once back on the job.
Four pathways covering the most frequent needs encountered in the field.
What you can do afterwards Read a regulation, identify the obligations that apply to your situation, structure the required technical documentation. No more enduring regulatory meetings without a reading framework.
Audience Management, quality managers, regulatory affairs, legal
What you can do afterwards Map your processes, draft your quality policy, prepare your management review. Based on your own documentation, not on generic cases.
Audience Quality managers, quality engineers, future quality managers
What you can do afterwards Build the clinical evaluation plan, steer the literature review, draft an auditable CER. The most common sticking point on Class IIa and IIb files.
Audience Clinical evaluators, regulatory affairs, medico-scientific teams
What you can do afterwards Identify hazards, estimate and evaluate risks, document control measures in line with the requirements of Annex I of the MDR. Without confusing residual risk and acceptable risk.
Audience R&D, quality, design and regulatory affairs engineers
Internal standard, specific customer requirement, hybrid format between training and operational support: we design tailored programmes based on your real file.
We start from your QMS, your procedures, your real cases. No repackaged generic content.
A one-day scoping session, a two-week assignment, a pathway spread over six months. The format follows your pace.
The same practitioners who run your consulting and audit assignments. No trainers disconnected from the field.
Tell us about your need (target course, inter or intra format, number of participants, preferred schedule). We get back to you within 48 hours with a firm proposal.
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