The Engineering Assurance Company

Turn product intent into an engineering environment your team can run

Engineering environments that stand up to compliance audit have always been built by hand. Kanzen is encoding that expertise into ComplianceMap™, our safety-critical systems engineering solution that generates the foundation of your development processes. Our process architects then tailor this foundation to your organization and help your teams make it part of daily work. ComplianceMap carries the knowledge. Our experts carry the judgment.

Experience ComplianceMap Book a Process Health-Check

Introduction

Product intent in, audit-ready engineering environment out

ComplianceMap turns a plain-language description of your product and regulatory context into a structured model of the engineering environment you need. It generates the processes, work products, workflows, and traceability for your ALM platform, giving your team a working starting point instead of a blank tool.

Kanzen’s process architects then validate the model, tailor it to your organization, and embed it into daily engineering work. The result is not just a configured platform, but an engineering process your teams understand, use, and can defend.

Your ComplianceMap Journey / 01 — 05

How it works

01

Type into the chat what you're building

01 — Describe

Describe your product, intended use, and industry context in plain language.

02

Be amazed as your data model takes shape

02 — Model

ComplianceMap maps the relevant standards, processes, work products, and traceability into one structured lifecycle model.

03

Watch your ALM tool configure itself

03 — Publish

The approved model is transformed into the corresponding structure, workflows, and traceability for your ALM platform and gets published with one click.

04

Meet the humans who make it stick

04 — Activate

Two of our experts, five days on-site. We tailor it, train your teams, and make it daily practice because a perfect environment nobody uses is really just a very tidy folder structure.

05

Relax as your process evolves through every regulatory shift

05 — Evolve & Govern

Through the Kanzen Accelerate methodology, our experts tailor the environment, train your teams, and embed it into daily work.

Over a decade of regulated engineering experience across 30+ programs

BMW Capgemini Volkswagen Group Innoviz ARTIDIS T-Systems Porsche Opsys Tactile TRUMPF Roche

Engineering organizations our team has worked with directly — in Kanzen engagements, through integration partners, and in earlier roles. All marks are the property of their respective owners; their inclusion does not imply endorsement of Kanzen.

Industry expertise

Built for the highest standards

Automotive

Build consistency and traceability.

Our Automotive industry accelerators bring together ASPICE, ISO 26262, and ISO/SAE 21434 process knowledge to structure requirements, safety, cybersecurity, testing, and traceability across the development lifecycle.

Relevant expertise: ASPICE · ISO 26262 · ISO/SAE 21434

Medical

Turn hazard control into routine.

Our MedTech industry accelerators model the development, risk, verification, and quality processes required for regulated medical-device development. Configured for daily work, not just audit documentation.

Relevant expertise: ISO 13485 · ISO 14971 · IEC 62304 · IEC 60601

Aerospace & Defense

Earn the "right to fly".

Our Aerospace & Defense industry accelerators help structure system, software, and hardware development evidence around the rigorous requirements of safety-critical avionics programs.

Relevant expertise: ARP4754A/B · DO-178C · DO-254

Working with Kanzen

How we work with your teams

Your reality is our reality.

We start with what you build, how your teams work, and where your greatest risks and opportunities sit.

Process first. Platform second.

We define what your engineering environment must achieve before setting up any technology behind it.

We work in the open.

Your stakeholders see and shape process models early, while changes are still easy to make.

Adoption is not an afterthought.

We work directly with your teams so the environment is understood, used, and confidently owned after rollout.

What our clients say

Trusted when it matters

Rami Ben-Ari

“…[it] couldn’t have been done without the support of Kanzen, which due to their vast and deep knowledge of ALM, their dedication, creativity for problem solving, […] made the entire process much easier.”

“...Highly Recommended!”

Rami Ben-Ari Software QA Manager,
Innoviz Technologies
Dr. Philipp Oertle

“Kanzen understands the needs of companies in a regulated environment and can configure ALM for all particular ISO 13485, ISO 14971 needs, as well as US regulations.”

Dr. Philipp Oertle R&D Manager,
Artidis AG
Head of Medical Device Development

“Kanzen enabled us to implement all relevant design, development, production and service processes and adapted [them] to our needs.”

Head of Medical Device Development

About us

Our experts carry the judgment

Kanzen is a global team of experts in safety-critical process engineering, functional safety, and ALM. Several of our team members started out as Codebeamer consultants at Intland (acquired by PTC) many years ago, and over a decade of implementations for OEMs, Tier 1 suppliers, and regulated startups, our practice grew beyond any single tool. What set us apart is we've always designed the processes first while making the platforms serve them.

We built these audit-ready engineering processes the only way it could be done: by hand, program by program, across 30+ regulated engagements. But those programs are now our Industry Accelerators. Those Accelerators became the models inside ComplianceMap. And today, ComplianceMap carries that reusable knowledge at software scale. Our process architects are the experts providing the judgment, validation, and organizational support each implementation still requires. This unique combination is why we are no longer just a consulting company, we're The Engineering Assurance Company.

Where engineering assurance goes next

Every safety-critical development program has (or should have) a logbook and a diary. The logbook is the ALM tool. It records who changed what, and when. This exists and works well with tools like Codebeamer, Visure, or Polarion. But the diary is the reason behind each change. Nobody writes the diary. When an engineer leaves, the reason leaves too. This is why we are extending the current ComplianceMap with what we call "Forensics". This new capability remembers why a product became what it is so engineers and auditors never have to reconstruct that story by hand again.

Start a conversation

Tell us where you're headed. We'll help you find the clearest way forward.

Compliance isn't a choice. How easily you achieve it is. Choose Kanzen.