Michael Luloh

AI Training for
Regulated Industries

The AI future is catching up extremely quickly. Are you ready? Practical AI guidance for engineering and R&D leaders in medical devices, pharma, and life sciences.

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The Challenge

Why isn't most AI training built for regulated industries?

The training options available to R&D leaders are either too generic (prompt engineering for beginners), too theoretical (strategy decks with no practical application), or too technical (ML courses built for data scientists). None of them account for design controls, 62304, 14971, audit trails, or the reality that "move fast and break things" don't work when the thing is a surgical instrument.

Our Approach

Reality over hype.

AI is a powerful tool that produces its best work if guided by domain expertise and good judgment. Without that, it generates confident-sounding output that can be generic, wrong, or risky in regulated environments. This training program focuses on what works reliably today, what's genuinely emerging, and what's still hype.

We help you make reliable decisions about AI. Not sell you on it.

The Format

About 45 minutes a week for each topic. Homework optional.

Traditional AI courses deliver a fixed curriculum that's outdated before you finish. This program is built to respond and evolve. Structured enough to build real capability, fluid enough to respond when the FDA drops new guidance or a tool changes overnight.

Live demos
Practical AI workflows you can use the same day. Not slides. Real tools, real work.
Weekly briefing
"What changed this week in AI," curated for regulated industries. We filter the noise so you don't have to.
Open Q&A
Current and relevant to your needs. Bring real problems, get real answers.
What We Cover

Topics include, among others:

Practical AI Skills
What works today, what's hype, and how to tell the difference, with live side-by-side comparisons
AI-assisted technical writing in regulated environments (and where AI may hallucinate dangerously)
AI for engineering leadership: synthesizing project status, spotting schedule risks, preparing for design reviews
AI in the Regulated Product Lifecycle
AI and IEC 62304: what's possible, what's permissible, what's coming
Accelerating DHF documentation without compromising compliance
AI for risk management (ISO 14971): hazard analysis, FMEA, and new risks AI introduces
Evaluating AI/ML-enabled medical devices: SaMD classification, FDA guidance, strategic implications
Agentic AI for Software Teams
Using agentic AI to write, review, and refactor production code in regulated codebases
AI-generated backlog items and product backlog management: from user stories to acceptance criteria
BDD test automation with AI: generating and maintaining behavior-driven test suites
Building a complete application by prompting an AI agent: a multi-session, hands-on walkthrough
Rethinking the dev team: how agentic AI shifts the balance toward prompt engineering and code review
Incorporating Strategic AI Leadership
Rolling out secure AI tools to your engineering team, without creating a compliance nightmare
AI vendor evaluation: how to cut through the pitch decks and avoid a 6-month POC that goes nowhere
A capability maturity map: what works now, what's emerging, and what's still vaporware, updated continuously
Your Instructor
Michael Luloh
  • Over 20 years in safety-critical software engineering, including Director-level R&D roles
  • Built real-time LASIK control software
  • Invented novel optical metrology methods for IOL production
  • Led development of cloud-based surgical planning platforms serving 100,000+ surgeries monthly
  • AAMI SM/WG 01 voting member on the IEC 62304 international standards committee
  • Founder of MedSafe (medsafe.dev), an AI-powered compliance documentation tool for medical device software that generates audit-ready IEC 62304 artifacts from existing dev tools
  • Hands-on with current AI tools and platforms: evaluating, building with, and training on them daily
Course Format Options
Individual

Weekly cohort sessions with peers from across the industry. Learn what's working, what isn't, and what to do about it.

Team

Privately contained and confidential cohort for your leadership team. Tailored examples, shared vocabulary, aligned decision-making.

Executive 1:1

Private and confidential instruction for leaders who need a trusted guide on AI strategy, vendor decisions, and org readiness.

Want to learn more?

michael_luloh@medsafe.dev (817) 734-8572