Generative AI for medical devices

[Translate to English:] Hände am Laptop mit Entwicklungscode

Making optimal use of generative AI in the development and approval of medical devices

Your challenge: AI is no longer a trend - it's business-critical

As a leading medical device manufacturer, you know: Without systematically leveraging AI, you will lose competitive advantages

To stay competitive while ensuring full compliance, organizations typically face these critical questions:

Where is the greatest ROI in AI deployment for development and approval processes?
How do you implement AI in compliance with the AI Act, ISO 13485, MDR, and IVDR to avoid regulatory risks?
How do you transform employees with AI reservations into engaged, highly productive teams with strong buy-in?

From Individual Experimentation to Systematic AI Excellence

We guide you systematically from isolated AI use to enterprise-wide transformation

01

Identify Options

We identify your AI potential, from automated document creation to risk analysis. After systematic evaluation, you start with quick wins for fast results and maximum ROI, while we develop your long-term AI strategy in parallel.

02

Create Roadmap

We provide structured support for your AI transformation, from the initial analysis to full implementation. With systematic milestones and measurable success criteria, we ensure sustainable change rather than short-lived flashes in the pan – giving you a lasting competitive advantage.

03

Implementation

We implement AI solutions together with your team in full compliance. Every AI application meets regulatory standards and is seamlessly integrated into the quality management system – securely and without compliance risks.

04

Stay Ahead

We continuously optimise and develop your AI systems. Regular updates keep you up to date with the latest technology and regulations – giving you a lasting innovative edge in the medical technology market.

[Translate to English:] man holding AI light bulb

01 - Identify Options

Your AI options systematically categorised

Low-hanging fruits: ➜ Implementation in days
Ready-to-use AI solutions for rapid efficiency gains without regulatory hurdles
Quick wins: ➜ Implementation in weeks to month
Development of specific prompts, agents and simple infrastructures with manageable effort
Strategic projects: ➜ Implementation in 1 - 2 years
Fine-tuning of LLMs, development of proprietary AI infrastructures for sustainable competitive advantages
Future outlook: ➜ Continuous implementation
Monitoring of future AI opportunities for your specific use cases

02 - Create Roadmap

Developing a structured roadmap

Resource planning: Align potential measures with available resources.
Time and budget planning: Create realistic schedules and budgets for all initiatives.
Project organisation: Define responsibilities and create agile structures.

03 - Implementation

Specific support during implementation

Staff training: Tailored training courses for all functions and employee levels
Technology and infrastructure: Support in selecting tools and setting up the infrastructure
Prompt and agent library: Building your own AI knowledge base
Project management: Professional support in all phases of transformation
QMS adaptation: Integration into ISO 13485 with full compliance
Regulatory compliance: AI Act, MDR, IVDR – including internal audits

[Translate to English:] Mann zeigt zwei Kollegen etwas am Laptop

04 - Stay Ahead

Always one step ahead – continuous support

Compliance monitoring: Continuous assurance of regulatory compliance as requirements change
From employee to super employee: Continuous training transforms your teams into AI super employees with exponentially increased productivity.
Technology updates: Further development of your prompts and agents in line with technological progress

Why the Johner Institute is Your Ideal Partner

With us at your side, you can master regulatory challenges more efficiently, shorten your time to market and secure decisive competitive advantages in medical technology.

No. 1 in Regulatory Affairs

You are working with the number one in regulatory affairs – we bring market-leading expertise to all your medical technology regulatory issues.

AI Pioneer since 2019

Not only have we been pioneers in artificial intelligence since 2019, we are also the authors of the EU-wide AI guidelines for notified bodies.

150+ Experts Worldwide

You are working with the number one in regulatory affairs – we bring market-leading expertise to all your medical technology regulatory approval issues.

Digital Leader

A pioneer in the digitalisation of our business model and the use of AI for maximum customer benefit.

Proven expertise

We know your challenges from our own experience and use this knowledge to develop tailor-made solutions that work in practice.

Transformation Expert

You benefit from our decades of transformation expertise: we digitise and automate your processes using proven methods from leading medical technology manufacturers and innovative enterprise SaaS solutions such as Regulatory Radar.

Start Your Systematic AI Transformation Now

Secure competitive advantages with full regulatory compliance

Contact us

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