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PRO-LIANCE CORE LEARNING
Digital & AI Transformation in RA/QM
From problem identification to practical, compliant and measurable implementation.

Duration

4 hours

Format Online

Language English

Challenges Addressed

  • Where can digitalisation and AI create real value in RA/QM? 
  • How can organisations avoid investing in tools before clearly understanding the underlying problem? 
  • How can unclear processes, poor data quality and organisational silos be addressed? 
  • How can digital solutions be implemented while maintaining compliance, validation, transparency and human oversight? 
  • How can digital transformation be prioritised, communicated and measured effectively? 

After the learning, participants will be able to

  • assess their organisation’s digital readiness, process maturity and key digitalisation opportunities, 
  • define a clear problem statement and develop a structured case for change, 
  • prioritise digitalisation, automation and AI use cases based on value, feasibility, data maturity and compliance requirements, 
  • develop stakeholder, change and communication strategies for cross-functional transformation projects, 
  • define meaningful KPIs and concrete next steps for implementation. 

Agenda

  • Digital and AI transformation in regulated RA/QM environments 
  • Common barriers and failure patterns using the TRIZ approach 
  • From pain point to a clear case for change 
  • The five-point roadmap: ideas, project setup, process analysis, implementation, completion and hypercare 
  • Stakeholder management, change and communication 
  • Use-case prioritisation: digitalisation, automation or AI? 
  • AI governance, validation, transparency and human oversight 
  • KPIs, ROI and a practical 30-day action plan 
 
 
 
Duration: 4 hours | Language: English | Modality: online (via Teams)

Practical Elements

The learning is highly interactive and includes a TRIZ exercise, a Case for Change Canvas, roadmap mapping, a stakeholder and communication matrix, use-case scoring, KPI development and the creation of a concrete 30-day action plan.

Participants work on a relevant RA/QM process or pain point from their own organisation. 

Who should attend?

Regulatory Affairs, Quality Management, Clinical Affairs, IT, Digital Transformation and management professionals, as well as project leaders and change champions in medical device companies. 

Recommended prior knowledge

Participants should have a solid understanding of medical device regulatory frameworks and quality management principles, as well as practical experience in regulated MedTech processes. No hands-on experience in digital or AI implementation is required. 

Why is participation worthwhile?

Participants learn how to turn digital and AI ambitions into a focused, compliant and measurable transformation approach that addresses real problems in RA and QM, rather than simply introducing another tool. 

PRICING AND REGISTRATION

Special offer for companies

Special offer for companys registering more than two participants (440.00 €/person excl. VAT) per company!

Early bird fee

Register 8 weeks prior to event and profit from our early bird fee (440.00 €/person excl. VAT)!

Normal price

Standard registration fee: 490.00 € excl. VAT

21 October 2026

Time 9:00-13:00 (CET)
REGISTER

16 December 2026

Time 14:00- 18:00 (CET)
REGISTER

10 February 2027

Time: 9:00-13:00 (CET)
REGISTER

13 April 2027

Time: 14:00-18:00 (CET)
REGISTER

FAQ

WHO IS THIS TRAINING FOR?

This training is designed for professionals working in Regulatory Affairs, Quality Management, Clinical Affairs, IT, Digital Transformation and management, as well as project leaders and change champions in medical device companies. Participants should have a solid understanding of medical device regulatory frameworks and quality management principles, together with practical experience in regulated MedTech processes. No hands-on experience in digital or AI implementation is required.

You will learn how to turn digitalisation and AI ambitions into a focused, compliant and measurable transformation approach. The training covers how to identify the right problems and opportunities, assess digital readiness and process maturity, prioritise digitalisation, automation and AI use cases, and develop stakeholder, change and communication strategies. You will also learn how to address AI governance, validation, transparency, human oversight, KPIs and ROI.

The training is highly interactive and focused on real-world application in regulated RA/QM environments. You will work on a relevant process or pain point from your own organisation using practical tools such as the TRIZ approach, Case for Change Canvas, roadmap mapping, stakeholder and communication matrices, use-case scoring and KPI development. By the end of the training, you will have a concrete 30-day action plan to support the next steps of your digital or AI transformation.

ADDITIONAL INFORMATION

  • Registration and event will be managed via Microsoft Teams. Billing and cancellation information will be sent to you via a separate email after registration.
  • Please note that the training will only take place if the minimum number of 4 participants is reached.
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