AI Integration for Medical Device Manufacturers - Johner Institute

Max out Generative AI in Medical Device Development and Approval

A proposal from the Johner Institute

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

1

Identify Options

• Identify AI potentials
• Categorize measures
• Set priorities

2

Create Roadmap

Structured planning for sustainable transformation

3

Implementation

Joint implementation with full compliance

Stay Ahead

Continuous optimization and development

Details on all steps can be found in the following sections:

1

Your AI Options Systematically Categorized

Low-hanging Fruits

Implementation: Days

Immediately deployable AI solutions for quick efficiency gains without regulatory hurdles

Quick Wins

Implementation: Weeks to months

Development of specific prompts, agents, and simple infrastructures with manageable effort

Strategic Projects

Implementation: 1-2 years

Fine-tuning LLMs, building proprietary AI infrastructures for sustainable competitive advantages

Future Watch

Continuous monitoring

Monitoring future AI opportunities for your specific use cases

2

Structured Roadmap Development

Resource Planning

Align potential measures with available resources

Time & Budget Planning

Create realistic timelines and budgets for all initiatives

Project Organization

Define responsibilities and establish agile structures

3

Specific Implementation Support

Workforce Upskilling

Tailored training for all roles & employee levels

Technology & Infrastructure

Tool selection and infrastructure setup support

Prompt & Agent Library

Building your proprietary AI knowledge base

Project Management

Professional support throughout all transformation phases

QMS Adaptation

Integration into ISO 13485 with full compliance

Regulatory Compliance

AI Act, MDR, IVDR - including internal audits

Stay Ahead - Continuous Support

Compliance Monitoring

Ongoing assurance of regulatory compliance with changing requirements

From Worker to Super-Worker

Continuous training transforms your teams into AI super-workers with exponentially increased productivity

Technology Updates

Evolution of your prompts and agents in line with technological progress

Why the Johner Institute is Your Ideal Partner

No. 1 in Regulatory Affairs: Leading expertise in all regulatory matters for the medical device industry
AI Pioneer since 2019: Author of the AI guidelines for Notified Bodies, adopted by the EU Commission
Digital Leader: Pioneering in digitizing our business model and leveraging AI for maximum client value
150+ Experts Worldwide: Support in all markets and jurisdictions
Transformation Expert: Decades of experience digitizing and automating processes for leading medical device manufacturers, with our Enterprise SaaS solutions like Regulatory Radar as proof of our digital excellence

Start Your Systematic AI Transformation Now

Secure competitive advantages with full regulatory compliance

Contact us:

[email protected]
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