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 empower your team with practical, actionable regulatory knowledge.
Customized programs
We tailor every training program to your specific products, markets, and team experience level.
Expert trainers
All sessions are led by experienced regulatory professionals with hands-on industry backgrounds.
Practical focus
We use real-world examples and case studies, including your own documentation where possible.
Measurable outcomes
We define clear learning objectives and provide post-training assessments to measure progress.
Ongoing support
Post-training follow-up sessions and Q&A support to reinforce learning.
Training topics
Our training portfolio covers a wide range of regulatory topics for medical devices and IVDs:
MDR & IVDR fundamentals
Comprehensive introduction to the EU Medical Device and In Vitro Diagnostic Regulations.
Technical documentation
Hands-on training in compiling and reviewing technical documentation under MDR/IVDR.
Post-market surveillance
Building effective PMS and vigilance systems that meet regulatory requirements.
Quality management systems
Training on ISO 13485 and regulatory QMS requirements under MDR/IVDR.
Why QbD Group
Your trusted partner
QbD Group's training programs are built on decades of hands-on regulatory experience across the MedTech industry.
700+ regulatory experts with deep domain knowledge.
Training programs tailored to your specific products and regulatory challenges.
Flexible delivery
on-site, virtual, or hybrid formats.
Post-training support and follow-up coaching available.
Proven track record with startups, SMEs, and multinational manufacturers.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.