About LIS Quality
We're not a big consulting firm — and that's a feature, not a bug. Every project is managed directly by the firm's partners.
Our Story
“We're not a big consulting firm — and that's a feature, not a bug.”
LIS Quality was founded in 2002 as an independent quality management and regulatory consultancy. Over the past two decades we have guided more than 244 projects across medical devices, biotech, aerospace, and manufacturing — in Israel, Europe, and North America.
What sets us apart: the person handling your registration is the owner — not a junior consultant who gets a brief at the end of the week. This approach means we work with fewer clients at any one time, but it is also why we maintain a 100% pass rate at official audits.
Our method is built on three principles: close partnership throughout the entire process, a mock audit before every official inspection, and building a single regulatory file that serves multiple regulators — invest once, deploy everywhere.
Close Partnership
We don't hand over documents and disappear. We work alongside your team — meetings, internal reviews, preparing your people for auditor questions.
Mock Audit Before Every Inspection
Before every official audit we run a full simulation. Surprises happen in rehearsal — not in the real thing.
One File, Multiple Regulators
We build a single technical file that speaks simultaneously to the FDA, AMAR, and MDR — one investment, triple the reach.
The Team
The people working on your project
No account managers. No junior staff. These are the experts who open your file on day one.
Shai Lis
Founder & Principal Consultant — Quality & Regulatory
Leading ISO 13485, FDA, MDR, and AS9100 projects since 2002. Every client gets direct, hands-on involvement — not a junior team.
Dr. Ina Borik
Clinical Consultant
Specializes in clinical evaluation and building technical files for European and US regulatory submissions. Brings research depth to every engagement.
Alex Gonorovsky
Quality & Regulatory Consultant
Specializes in building quality management systems and preparing organizations for official audits. Extensive experience with leading certification bodies.
Dr. Lis Leonid
Clinical Consultant
Expert in bio-clinical evaluation and clinical documentation requirements under MDR and FDA. Supports clients through product development and classification.
Our Vision
To prove that a small firm can deliver regulatory consulting at a level the big players simply cannot match — because here, the partner is the one opening your file, not their assistant.
Our Mission
To help manufacturers and developers pass regulatory audits on the first attempt — without unnecessary delays, without surprises, and with a file that serves them for years to come.
Ready to get started?
A 15-minute intro call — no cost, no commitment. We will understand your product, your market, and your timeline, then come back with a precise recommendation.