Technical documentation is the basis for product approval as a medical device or in-vitro diagnostic device. This course gives participants a practical framework for understanding where digitalization and AI can create real value in technical documentation – and how to approach implementation in a controlled, compliant, and useful way.
Many manufacturers still maintain technical documentation manually across Word, Excel, SharePoint, DMS, PLM, and other systems. This course provides practical guidance on how to move towards automated, data-based, and digitally supported TD processes, what needs to be considered before implementation, including how to evaluate the appropriate system(s) for a digitized TD, and where AI-supported functions may provide value in regulated environments.
PARTICIPANTS
This course is suitable for participants with and without prior experience in digital technical documentation. It is particularly relevant for Regulatory Affairs, Quality Management, PRRCs, technical documentation managers, R&D/Engineering teams, manufacturers of medical devices and IVD, consultants, industry newcomers, and start-ups.
This basic course is part of our online course: Regulatory Specialist EU-MDR-IVDR.
THE SEMINAR CONTENTS
- Understand the basics of digital technical documentation: what changes when TD moves from Word, Excel, SharePoint or DMS towards more structured and system-supported processes.
- Learn how to build a data-driven TD with a single source of truth, so information is not maintained repeatedly across documents and teams can reduce manual work, inconsistencies, and avoidable errors.
- See how AI can support technical documentation in a controlled way, for example for reviews, consistency checks, evidence checks, and change proposals, while keeping human review and regulatory responsibility clearly in place.
- Understand the key compliance expectations for digital TD and AI use, including traceability, audit trails, access control, data protection, version control, and Computer System Validation.
COSTS
- Early bird (until 4 weeks before seminar): Euro 150,- (excl. VAT)
- Standard (starting 4 weeks before the seminar): Euro 190,- (excl. VAT)
- All seminar discounts at a glance
- incl. seminar documents as PDF and a certificate of participation.
YOUR TRAINER
Lukas Poterpin, Co-Initiator & Lead Regulatory Affairs, Confideck GmbH
LOCATION: ONLINE
The seminar will be interactive – similar to a face-to-face seminar: i.e. you can ask your questions to the lecturer, there will be exercise examples and also the possibility to exchange ideas with the other participants.