Consulting
Reliable consulting from real experts
Navigating MDR, IVDR, or the new EU AI Act compliance landscape isn’t easy — but you don’t have to do it alone.
We help you find your way through the regulatory maze and support you step by step to ensure your company meets all requirements.
Whether you’re a manufacturer, distributor, importer, PRRC, or compliance specialist, we understand the challenges you face every day.
In addition to NoBoVersum’s premium training courses, we offer tailor-made consulting services for organizations dealing with regulatory challenges in medical devices and artificial intelligence.
Our goal is to provide practical, targeted support for those who need not only to learn, but also to take action to achieve compliance.
Whether you need help with a specific question or a complete compliance strategy — you can count on us.
Fill in the consultation request form, and we’ll get back to you within 2 business days.
Our Expertise
Comprehensive consulting for manufacturers, distributors, and importers
- For manufacturers
- Device risk classification
- Identification of applicable requirements and standards
- Selection of conformity assessment routes
- Clinical evaluation pathway planning and execution
- Technical documentation in line with MDR/IVDR requirements
- Post-market surveillance system development
- For distributors
- General obligations under MDR/IVDR
- Inspection, information, and record-keeping duties
- Mandatory communication with manufacturers and authorities
- For importers
- Pre- and post-market obligations
- Vigilance support
- Communication requirements with non-EU manufacturers, authorized representatives, and authorities
- For PRRCs (Person Responsible for Regulatory Compliance)
- Support in daily compliance decision-making
- Technical Documentation (Annex II MDR/IVDR)
- Device description
- Information provided by the manufacturer
- Identification of design and manufacturing requirements
- GSPR compliance
- Benefit-risk analysis
- Product verification and validation
- Clinical Investigations
- Planning, approval, and execution of medical device clinical investigations
- Planning, approval, and execution of performance evaluation for IVD devices
- Strategic and operational support
- Audit and certification preparation
- Full consulting for medical device developers entering the market under MDR/IVDR requirements
Prepare your organization in time for the new regulation:
- Risk-based classification and registration
- Quality management and documentation support
- AI governance framework development
- AI Impact Assessment and compliance-by-design
- Customized compliance roadmap and action plan
- Mentoring for AI developers, distributors, and compliance teams
We don’t just follow EU AI Act developments — we actively help organizations put compliance into practice.
Didn’t find exactly what you need on the list?
Every situation is unique — and this is exactly where we excel.
Thanks to our extensive expert network and broad regulatory experience, we can find solutions even for complex or highly specialized challenges.
Request a consultation, and together we’ll shape the support that best fits your needs.
Why Choose Us?
✓ Specialized in medical device and AI regulation
✓ Trainers who are also consultants — theory and practice in one hand
✓ Internationally relevant experience
✓ Extensive expert network to find the right solution for every challenge
✓ Fast, flexible, and personalized support