Professional regulatory consulting
since 2002.
An independent quality management, certification and regulatory affairs consultancy — for medical device manufacturers, aerospace companies and industrial plants. Proven expertise across Israel, Europe and North America.
Trusted by industry leaders
Our Core Specialties
Services that work as standalone projects or as a complete regulatory roadmap
One technical file, multiple regulators — significant savings in time and resources throughout the certification process.
ISO 13485
Quality management system for medical devices. QMS implementation per 13485:2016, ready for FDA QSR and MDR. Full support through certification.
AMAR Registration
Medical device registration with the Israeli Ministry of Health. Regulatory classification, AMAR file preparation and submission to the Medical Devices Division.
CE / MDR
European marking under 2017/745. Regulatory strategy, technical file, Clinical Evaluation, and end-to-end support with your Notified Body.
FDA 510(k)
U.S. market clearance. Preparation and submission of the 510(k) file, FDA correspondence, and QMS alignment with the Quality System Regulation.
AS9100
Aerospace and defense quality standard. Implementation and maintenance of QMS for civil and defense aerospace, including NADCAP readiness.
ISO 9001
Generic quality management system. The foundational standard for industry and B2B services, tailored to customer requirements and major tenders.
Industries where regulation isn't friction — it's the price of market entry
Every industry has its own language, regulators, and protocols. Our expertise was built on the floor, working with quality managers and leading manufacturers.
Medical Devices & Biotech
From first-product startups to international manufacturers requiring registration in Israel, Europe and the United States.
Aerospace & Aviation
Subsystem manufacturers and suppliers serving the civil and defense aviation market, certified to AS9100 and NADCAP standards.
Manufacturing & Industry
Production plants and B2B companies that need quality management systems to meet the requirements of strategic customers.
Our Story
“We're not a large consulting firm — and that's a feature, not a bug.”
Lis Quality was founded in 2002 as an independent consulting firm. Every project is led directly by the firm's partners — not a junior team.
Our methodology is built on three principles: hands-on guidance, a mock audit before every official inspection, and a single regulatory file that serves multiple regulators.
“Working with them is different. They don't give you a checklist of documents — they build them with you. By the end we didn't just pass the audit, we work differently today.”
Knowledge & Resources
Tools and articles we use ourselves, every day
How to Choose a Notified Body for CE/MDR
A practitioner's checklist: NB capacity crunch, how to read Annex IX/X/XI in NANDO, and the five questions every MedTech CEO should ask before signing.
Read Full Article
MDR vs MDD: What Really Changed and Why It Changed Everything
The shift from one-time approval to lifetime obligation. A practical review of the differences that actually affect your technical file — comparison table included.
Read Full Article
ISO 14971: A Practical Risk Management Guide
ISO 14971:2019 + Amendment 1 (2024). Risk Management File structure, five common deficiency patterns NBs flag, and how it links to MDR Annex I GSPRs.
Read Full ArticleHave a project? Let's talk.
A 15-minute introductory call — no cost, no obligation. We'll understand the product, the market and the timeline, then come back to you with a precise recommendation.
Israel
Rehovot · 7 Carmel St
Maalot · 16 Snir St
Canada
Bradford, Ontario, ON
North America Office