Coaching & Training
Build regulatory competence within your team
QbD Group offers tailored training programs designed to build practical regulatory competence for medical device and IVD teams, from MDR/IVDR fundamentals to advanced technical documentation.
What is regulatory coaching & training?
Navigating the regulatory landscape for medical devices and IVDs requires specialized knowledge that evolves continuously. Whether your team is new to MDR/IVDR or needs to deepen existing expertise, targeted coaching and training can significantly accelerate your regulatory readiness.
QbD Group offers tailored training programs designed to build practical regulatory competence within your organization. Our training goes beyond theory — we focus on real-world application, using your own products and documentation as case studies wherever possible.
From one-day introductory workshops to multi-week deep-dive programs, our training is designed to fit your team's needs and schedule.
How we support you
Our coaching and training services are designed to strengthen your team's practical regulatory understanding and application.
Customized programs
We tailor training content to your products, markets, and the experience level of your team.
Expert trainers
Sessions are delivered by experienced regulatory professionals with hands-on industry backgrounds.
Practical focus
We use real-world examples and case studies, including client-specific materials where appropriate and agreed.
Learning reinforcement
We define learning objectives and can provide optional assessments or follow-up discussions to support knowledge retention.
Ongoing support
Follow-up sessions and Q&A support can be provided to reinforce key topics after training.
Training topics
Our training portfolio covers a range of regulatory topics for medical devices and IVDs:
MDR & IVDR fundamentals
Overview of the EU Medical Device and In Vitro Diagnostic Regulations.
Technical documentation
Practical guidance on compiling and reviewing technical documentation under MDR/IVDR.
Post-market surveillance & vigilance
Introduction to PMS requirements and vigilance processes under MDR/IVDR.
Quality management systems
Training on ISO 13485 and QMS expectations under MDR/IVDR.
Why QbD Group
Your trusted partner
QbD Group's training programs are based on extensive hands-on experience in the MedTech regulatory environment.
Experience delivering regulatory training across startups, SMEs, and multinational manufacturers.
Training adapted to different organizational maturity levels and product types.
Flexible delivery formats, including on-site, virtual, or hybrid sessions.
Optional follow-up support and coaching after training sessions.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.