You built the device.
Now you need a QMS that passes FDA.
244 projects. 100% success rate at official audits.
Shai Lis writes the documents — your team keeps building.
- QMS that passes FDA audits
- Technical file that meets MDR
- Risk management per ISO 14971
- Mock audit before the real one
- Post-market support (PMS, PMCF)
“When you trust us with the details — you're trusting them to me personally.” — Shai Lis, CEO, LIS Quality, leading every project since 2002
Since 2002, 244 projects — zero audit failures.
Why It Matters
ISO 13485 is the foundation for every regulatory certification in medical devices.
It is the international quality management standard for medical devices — built around strict requirements for risk management, traceability, and supplier control. Any manufacturer that wants to sell in Europe (CE/MDR), in the US (FDA), or to register with AMAR in Israel must have this standard as the baseline.
Structured process from day one to your certification on the wall
One technical file that works for FDA, MDR, and AMAR in parallel
Your team keeps building — we work against the QMS, not against you
Weekly communication — you always know exactly where we stand
Sound familiar?
You built a great medical device. Now they're asking for a full technical file.
Your team is R&D — not quality. You built the company fast, and now your time-to-market depends on how quickly you can produce documents you have never seen before. We know this story very well.
There is no real QMS — just files in a few Drive folders. When the FDA timeline arrives, a deep gap in the quality system is suddenly exposed.
You set an FDA submission date. Now your time-to-market depends on how fast you can get certified — without halting product development.
You built everything to MDD. Now the Notified Body wants PMCF, EUDAMED, and expanded documentation — and there is no one to do it.
Your engineers want to build product. No one wants to stop everything and spend three months drafting procedures.
How it works
A 6-step process: from day one to certification in hand.
Every step has a clear deadline, defined points of contact, and one concrete deliverable that you receive.
Gap mapping — a clear roadmap, fast
A rapid review of what you already have — procedures, documents, technical files. An intro meeting with your team, and a precise roadmap of what is missing, what needs improving, and the exact timeline. No commitment, free of charge.
A tailored quality system — not off-the-shelf templates
Procedures, work instructions, records, and control tools — all aligned to ISO 13485:2016. Written in Hebrew or English, tailored to how your company actually operates. We write it; you approve it.
A Technical File that holds up to a Notified Body or FDA
A full technical file at the highest level — including safety verifications, clinical evidence, reliability testing, and conformity analyses. Ready to be submitted to an external auditor without a single comment.
Full risk management per ISO 14971
A complete FMEA, risk analysis across the entire product lifecycle, and documentation that is audit-ready. We work in Excel or in Greenlight Guru — whichever fits you best.
Mock audit — the audit before the audit
A full simulation of the official audit. We catch the last gaps, train your team how to respond to auditor questions, and make sure there are no surprises. After this stage, you are ready.
After the certificate — we are still here
PMS (Post-Market Surveillance), PMCF, EUDAMED registration, and annual surveillance audits. Certification is not the end — we stay with you across the full product lifecycle.
Why LIS Quality
Israeli MedTech companies choose us for three reasons — focus, accountability, and results.
Medical devices only
No generic ISO standards. MedTech only. Our team has worked with the FDA, the new MDR, and Israel's medical device division — inside the same company.
100% success rate at official audits
We have never come back with a critical NC. Not once. Our mock audit catches everything before the official auditor walks into the room.
We write the documents. You approve them.
We don't send you a PDF of 'what to do.' We draft every document ourselves and respond directly to the Notified Body — your team keeps building.
23+ years of industry experience
Shai Lis has led FDA certifications, CE approvals under MDR, and AMAR registrations for 244+ companies. Regulation is not a hobby for us.
One-stop for the entire regulatory journey
13485, AMAR, CE, FDA, ISO 14971 — all under one roof. One technical file, four approvals.
No price surprises
One comprehensive proposal with deadlines. No 'additional fixes,' no open billable hours.
Meet Shai Lis
23 years of experience. 244 projects.
Zero audit failures.
Shai Lis has led LIS Quality since 2002. Previously, he built quality systems inside Israeli and international defense and medical device companies. He is an expert in ISO 13485, MDR, and FDA QSR — and has been a partner in countless AMAR registrations with Israel's medical device division.
He personally manages every project — never a junior team. Why? “When you trust us with the details, you're trusting them to me.”
What Our Clients Say
Without the professional guidance and support of Shai and the LIS team, we could not have met the standard's requirements. We gained immensely from his deep knowledge and extensive experience in work processes, especially in our facility.
To Shai and the dear team — after a challenging ISO 13485 audit day, I want to thank you for your professional approach to understanding our organization's unique needs, your creative thinking in finding solutions, and the specific tailored work methods that aren't visible on the surface.
Trusted by industry leaders
Frequently Asked Questions
What MedTech CEOs ask us before getting started.
How long will it take us to reach ISO 13485 certification?+
It depends on your starting point. If you already have basic procedures, we'll finish faster. If you're starting from zero, we'll build the QMS in parallel with development. Either way, we work to an agreed schedule with clear milestone dates.
Will our team have to stop product development?+
No. We work against the QMS, not against you. Your team commits a small amount of time to review meetings — we do the rest. Development continues in parallel.
How does ISO 13485 connect to FDA / CE / AMAR?+
ISO 13485 is the foundation. If you have a QMS aligned with 13485, it covers about 80% of FDA QSR requirements (21 CFR 820), the Quality Management System requirements of the European MDR, and most AMAR requirements. We build a single file that serves all of them.
What happens if we fail the certification audit?+
It hasn't happened to us in 244 projects. The reason: before the official audit, we run a mock audit — an internal audit that mirrors the real one precisely. Every gap is uncovered and fixed before the auditor walks into the room.
We're a small startup (8 people). Are you a fit for us?+
Yes. Most of our clients are startups with 5–30 people. We know how to build a proportionate QMS that won't suffocate a small team — and that will still pass any audit.
Do you handle the new MDR and not only the legacy MDD?+
Yes, with particular focus. The MDR (2017/745) introduced new requirements — PMCF, EUDAMED, expanded Technical Documentation, stronger clinical evidence. We've worked to MDR from day one, not the deprecated MDD.
How much does it cost?+
Every project has variables — the type of device, regulatory class, starting point, and the scope of any existing QMS. In a 15-minute consultation we can give you a precise range. Full disclosure — there are no 'extras' afterwards.
We also need CE / FDA / AMAR. Do you handle that?+
Yes. Most of our clients need several approvals in parallel. One file, several approvals — significant savings in time and cost.
Complete the regulatory journey
Need AMAR or ISO 9001 too? We handle the entire path.
AMAR approval for medical devices
Registration with Israel's medical device division — from device classification to certificate in hand.
Go to AMAR pageFoundation standardISO 9001 certification
A quality management system for general industry — on an agreed timeline, without halting production.
Go to ISO 9001 pageComprehensive consultingNot sure where to start?
A 15-minute call — we'll come back to you with a precise plan based on your product and target market.
Book a callLet's get started
15 minutes. You'll walk away with a precise gap map — what you have, what's missing, how long it takes.
We'll talk through your device, your target markets, and your regulatory deadline. You'll receive a clear map by email: what you already have, what's missing, and how long it'll take. No commitment. No pressure pitch.
Three fields. We'll come back with a professional assessment — not a high-pressure pitch.
No commitment. No mailing list. We reply within one business hour.