AI Act Compliance Fast Track - Johner Institute

AI Act Compliance Fast Track

Transform regulatory challenges into competitive advantages – with the leading experts for Medical Device and AI Compliance

Challenges You Already Know

  • Uncertainty about AI Act requirements for AI-based products and tools
  • Unclear which standards and guidelines must be applied
  • Looming issues with Notified Bodies and authorities
  • No overview of effort, affected teams, and where to start

Hidden Risks Lurking

  • Unconscious violations of MDR/IVDR in AI development
  • AI development without specific QM requirements
  • Duplicate work: Legal handles AI Act, RA handles MDR
  • Result: Redundancies, contradictions, and dangerous gaps

Your Path to AI Act Compliance in 4 Phases

1

Quick Check

Status assessment & gap analysis

2

Roadmap

Prioritized action planning

3

Implementation

Joint execution

Stay Ahead

Continuous compliance

1

Quick Check / Assessment

  • Gap analysis of your QM systems regarding AI Act, MDR/IVDR and AI standards
  • Review of technical documentation for an exemplary AI product
  • Overview of deployed AI tools and their compliance status
  • Current state description with prioritized recommendations
  • Optional: Board presentation for awareness building
2

Roadmap Development

  • Prioritization of measures by regulatory risks
  • Alignment with available resources
  • Detailed time, budget, and resource planning
  • Definition of project organization
  • Roadmap usable for Notified Bodies
3

Implementation

  • Creation of SOPs for AI tool qualification
  • Requirements for AI medical devices per AI Act, MDR/IVDR
  • Building an integrated management system (ISO 13485 + ISO 42001)
  • Revision of technical documentation
  • Training of all affected teams

Stay Ahead - Continuous Support

  • Monitoring of technological and regulatory changes
  • Specific recommendations for new requirements
  • Regular compliance audits
  • Ongoing employee training
  • Identification and leverage of productivity potentials

Your Benefits at a Glance

🎯

Lean Compliance

Maximum efficient QM system with full conformity

Fast Market Access

No delays from authorities or Notified Bodies

🛡

Regulatory Security

Avoid fines and market withdrawals

🚀

Efficiency Boost

Optimized processes without redundancies

👥

Organizational Clarity

Clear responsibilities and workflows

💡

Internal Competence

Enablement for independent development

Why Specialized Medical Technology Expertise is Crucial

No. 1 in Medical Device Regulatory: Deep industry expertise instead of surface-level consulting
150+ Specialized Experts: Focused on medical technology across all jurisdictions
AI Pioneer since 2019: Author of the AI guidelines adopted by the EU
Digital Pioneer: Own enterprise SaaS solutions like the Regulatory Radar

Secure Your AI Act Compliance Now

Let's make your AI products and tools compliant and successful together

[email protected]
X

Privacy settings

We use cookies on our websites. Some of them are essential, while others help us to improve this website and your experience.