Medical Device Software Consulting

Compliance is not a gate.
It's how you ship faster.

LOV Consulting helps medical device software teams build IEC 62304-compliant SDLC processes designed for the AI-accelerated world — so regulatory review becomes a formality, not a bottleneck.

25+
Years in medical device software
FDA.
510(k) & EU MDR submissions delivered
Day 1
Compliance built in from the start

The problem

Compliance is still an afterthought.

Most medical device software teams treat regulatory as a final gate. Build the product, then prove it's compliant. Scramble to reconstruct evidence. Respond to findings. Repeat. Meanwhile your burn rate doesn't pause, your competitors don't wait, and the AI-driven feature set you designed 18 months ago is already table stakes by the time you clear review.

In an AI-accelerated world, a delayed submission isn't just expensive — it can be existential. The real cost isn't the remediation. It's the opportunity you never got back.

$500K–$2M+
Remediation cost after a failed FDA audit or Form 483
$300K–$900K
Runway burned in a two-cycle notified body review
6–18 mo
Market access lost to back-and-forth that could have been avoided

Our approach

Shift left.
Build compliance in
from day one.

Not waterfall vs. agile. Not iterative vs. evolutionary. That debate is over. The only thing that matters now is whether your entire team — engineering, quality, regulatory — can move together at speed, with everything done in parallel and nothing blocking the next step.

01
Requirements written compliance-ready from day one
Traceable, verifiable, 62304-aligned before a line of code is written. No reconstruction, no retrofitting.
02
Compliance evidence as a byproduct of work
Anomalies, change controls, and release decisions documented as they happen — not assembled in a pre-submission scramble.
03
Risk tied to functionality throughout development
ISO 14971 risk management embedded in the SDLC — derived from device functionality, not bolted on at the end.
04
AI acceleration with a compliant foundation
AI tools compress development cycles. The right process provides the structure that makes that acceleration safe and auditable.

Services

What we do

Practical, hands-on engagements — not slide decks. We work alongside your team to build the foundation that makes everything else work.

SDLC Process Design & Implementation
End-to-end IEC 62304-aligned software development lifecycle design — development process, configuration management, anomaly management, release process, and cybersecurity. Built for your team, your tools, your stage of growth.
AI-Assisted Development Integration
Practical frameworks for incorporating AI coding tools, automated testing, and accelerated development workflows into a regulated environment — so you move faster without creating audit risk.
Regulatory Readiness & Audit Preparation
Pre-submission process review, technical file readiness assessment, gap analysis against FDA and notified body expectations. Know where you stand before the auditors do.

Ready to make compliance
your competitive advantage?

Let's talk about where your process is today and what it would take to get it to where it needs to be.

About

Horst Pichler

25 years building medical device software organizations that ship compliantly and move fast. Now helping others do the same.

Born and raised in Graz, Austria, Horst holds a degree in Nachrichtentechnik und Elektronik from HTBLuVA Graz Gösting and a Master's degree in Telematik from Technische Universität Graz — one of Europe's most rigorous technical programs combining computer engineering, networking, and systems design. He moved to the United States in 2003.

Over the course of his career, Horst has held senior and executive software engineering leadership roles at medical device companies including Inogen and Caire — building development organizations from the ground up and guiding software teams through the full product lifecycle, from architecture and process design through regulatory submission, audit, and commercial release.

His expertise spans IEC 62304-compliant SDLC design, ISO 14971 risk management, configuration management, anomaly management, release process, and cybersecurity for medical devices — with hands-on experience navigating FDA submissions and notified body reviews on both sides of the Atlantic.

Horst is an early practitioner of AI-assisted software development in regulated environments — not just as a productivity tool, but as a fundamental shift in how teams can move faster while keeping their compliance foundation intact. He documents this journey through his LinkedIn series on AI-assisted development in medical device software.

LOV Consulting was founded on a simple premise: in an AI-accelerated world, the medical device companies that win are the ones who figured out how to move fast and stay compliant at the same time. Not as competing goals — as the same goal.

HP
Horst Pichler
Founder, LOV Consulting
San Francisco Bay Area, CA
25+ years in medical device software
CSM · CSPO
M.Sc. Telematik, TU Graz
Active on LinkedIn

Background & expertise

Primary standard
IEC 62304 — Medical device software lifecycle
Risk management
ISO 14971 — Application to medical devices
Industry experience
Inogen, Caire — respiratory & medical device software
Emerging practice
AI-assisted development in regulated environments
Certifications
Certified ScrumMaster (CSM) · Certified Scrum Product Owner (CSPO)
Regulatory experience
FDA 510(k) · EU MDR · Notified body reviews

Leadership philosophy

The best teams
organize themselves.

"A leader's job is to create the right environment, the right incentives, and the right guardrails — then trust the team to deliver."

"Good engineering practice and regulatory compliance aren't two different goals. In this industry, they're the same goal."

Let's build something
that actually ships.

Book a consultation and let's talk about where your process is and what it would take to get where you need to be.