Easy13485 · Journey Pricing 2026

Determine your path.
Transparent. Tailored. Yours.

Every regulatory journey is different — by product type, risk class and where you are right now. Select your customer type and Journey stage, and the calculator builds your individual offer. Download it directly as a PDF.

Step 1 Select your customer type
Step 2 Choose your Journey stage
Step 3 Get your price, download as PDF
Before your first call

Know your number before you talk to us.

This isn't a final quote — it's your starting point. Build your Journey below to get an indicative monthly price, then bring that number into your free first call. We'll go through it together and confirm it against your actual product and team.

💡

How the calculator works: pick your customer type, then the Journey stage that matches where you are right now. Add-ons like Easy Expert, ISMS or AI Act only apply if you actually need them — the calculator only shows the ones relevant to your selection.

Example calculation Software startup, Class IIa, 10 employees
Stage 03 / 05
01 · Customer type
Software as a Medical Device (SaMD)
02 · Risk class & team
Class IIa · up to 10 employees → Essential plan
03 · Journey stage
Build, Verify & Document
Resulting monthly price 990 € excl. VAT, no add-ons

Every stage includes everything before it — pricing is not additive. Moving to the next stage later replaces this price, it doesn't add to it. Your own numbers may differ by customer type, risk class, team size and add-ons — build your exact case below.

Easy13485 · Journey Pricing 2026
Journey Calculator — Your Solution

Easy13485 · Journey Pricing 2026

Journey Calculator

Select the stage that fits where you are. Your need and your price appear automatically.

Our need
Claim Check — Entry diagnosis

Start here — before committing to a Journey stage.

The Claim Check clarifies whether Light, Essential or Certified fits your product, team and regulatory situation — and at which Journey stage you should start. Fully creditable within 90 days when a Journey stage is booked.

1.920 €one-time · excl. VAT
1.344 €trade fair price (−30%)
How the Journey works

Not every path is the same.

The Easy13485 Journey is structured in five stages — but which stages apply to you depends on your customer type. The Claim Check confirms your path before any commitment.

01
Claim Check
Confirms product line (Light / Essential / Certified), scope and your correct entry stage. One-time — 100% creditable within 90 days.
All customer types
02
Explore & Plan
Claim logic, intended use, Clinical Pathway, Prepare Clinical Investigation Input - not for contract manufacturers or custom-made devices.
Standard MD · Non-active MD
03
Build, Verify & Document
Controlled development documents, Medical Device File, verification logic and traceability. Risk-based development - also relevant for Non-Medical Devices.
Standard MD · Non-active MD · Non-MD
04
Automate
Easy Expert General included for all. Custom and Config License as optional uplift for Essential and Certified - AI on your QMS structure, not on document chaos.
All with Build scope
05
Operate & Scale
Full QMS operation: QMSaaS, roles, PMS/CAPA, Management Review and annual Readiness Audit. Scope and price reflect what your customer type actually needs.
All customer types

Higher Journey stages include previous stages — pricing is not additive. When you move to the next stage, the new monthly price replaces the previous one.

Easy13485 · Journey Pricing 2026
Journey Calculator — Your Solution

Easy13485 · Journey Pricing 2026

Journey Calculator

Select the stage that fits where you are. Your need and your price appear automatically.

Our need
Claim Check — Entry diagnosis

Start here — before committing to a Journey stage.

The Claim Check clarifies whether Light, Essential or Certified fits your product, team and regulatory situation — and at which Journey stage you should start. Fully creditable within 90 days when a Journey stage is booked.

1.920 €one-time · excl. VAT
1.344 €trade fair price (−30%)
Existing customer? If you have a contract that started before 01.07.2026, your Legacy pricing applies.
Open Legacy Calculator
Frequently asked questions

What people ask before they calculate.

Q 01 What does ISO 13485 certification cost for a MedTech startup?
For a Class IIa startup using Easy13485, typical IPP advisory costs for full MDR conformity are approximately 20,000 €. QMS structure and operation are covered by the Easy13485 Journey monthly fee (from 390 €/month), which replaces open-ended consulting retainers. Notified Body audit fees are not included — they vary by NB and device complexity. The calculator above shows your individual monthly figure.
Q 02 What is the difference between a Class I self-declared CE mark and a Class IIa ISO 13485 certification?
Class I devices (most non-active, non-sterile, non-measuring) can be placed on the market via a self-declaration of conformity under MDR — no Notified Body audit required. Class IIa and higher require a Notified Body to audit your QMS and review your technical documentation before CE marking. The calculator shows which product line applies to your device class.
Q 03 How long does CE certification take for a Class IIa medical device?
With Easy13485, teams have reached ISO 13485 certification for Class IIa devices in as little as 5 months from QMS setup. ISO 13485 certification covers the QMS — no product file or technical documentation is required at this stage. The MDR conformity assessment, including technical documentation and clinical evidence, follows separately. The Claim Check confirms a realistic timeline for your specific device and scope.
Q 04 What is the Easy13485 Claim Check and what does it cost?
The Claim Check is a paid one-time entry assessment at 1,920 € (excl. VAT). It confirms whether Light, Essential or Certified fits your product, clarifies your intended use and risk class, and determines which Journey stage is the right starting point. The full amount is creditable against a booked Journey stage within 90 days.
Q 05 Can a dental laboratory or contract manufacturer use Easy13485?
Yes. Custom Made Devices (e.g. dental labs) and Extended Workbench / contract manufacturers have their own customer type in Easy13485. These enter directly at Operate & Scale — no Explore & Plan or Build phase required. The QMS covers supplier management, CAPA and Management Review at a reduced monthly rate from 290 €/month.
Q 06 Does Easy13485 work for software that is not a medical device?
Yes. Clinical software, performance tools and other products requiring ISO 13485 QMS structure without medical device status have a dedicated Non-Medical Device track in Easy13485 Light. Risk-based development (Build, Verify & Document) and full QMS operation are available from 300 €/month.
Frequently asked questions

What people ask before they calculate.

What does ISO 13485 certification cost for a MedTech startup?

For a Class IIa startup using Easy13485, typical IPP advisory costs for full MDR conformity are approximately 20,000 €. QMS structure and operation are covered by the Easy13485 Journey monthly fee (from 390 €/month), which replaces open-ended consulting retainers. Notified Body audit fees are not included — they vary by NB and device complexity. The calculator above shows your individual monthly figure.

What is the difference between a Class I self-declared CE mark and a Class IIa ISO 13485 certification?

Class I devices (most non-active, non-sterile, non-measuring) can be placed on the market via a self-declaration of conformity under MDR — no Notified Body audit required. Class IIa and higher require a Notified Body to audit your QMS and review your technical documentation before CE marking. The calculator shows which product line applies to your device class.

How long does CE certification take for a Class IIa medical device?

With Easy13485, teams have reached ISO 13485 certification for Class IIa devices in as little as 5 months from QMS setup. ISO 13485 certification covers the QMS — no product file or technical documentation is required at this stage. The MDR conformity assessment, including technical documentation and clinical evidence, follows separately. The Claim Check confirms a realistic timeline for your specific device and scope.

What is the Easy13485 Claim Check and what does it cost?

The Claim Check is a paid one-time entry assessment at 1,920 € (excl. VAT). It confirms whether Light, Essential or Certified fits your product, clarifies your intended use and risk class, and determines which Journey stage is the right starting point. The full amount is creditable against a booked Journey stage within 90 days.

Can a dental laboratory or contract manufacturer use Easy13485?

Yes. Custom Made Devices (e.g. dental labs) and Extended Workbench / contract manufacturers have their own customer type in Easy13485. These enter directly at Operate & Scale — no Explore & Plan or Build phase required. The QMS covers supplier management, CAPA and Management Review at a reduced monthly rate from 290 €/month.

Does Easy13485 work for software that is not a medical device?

Yes. Clinical software, performance tools and other products requiring ISO 13485 QMS structure without medical device status have a dedicated Non-Medical Device track in Easy13485 Light. Risk-based development (Build, Verify & Document) and full QMS operation are available from 300 €/month.

Get ready

Get ready.
Then let's talk.

Three steps, about 30 minutes — so your 45-minute call is about your situation, not the basics.

Step 1 · Get informed · ~20 min

Know your duties

16 short videos, 30 seconds each — what you're responsible for as a medical device manufacturer.

Start the free module →
Step 2 · Get prepared · ~10 min

Show us where you stand

Fill in the self-assessment and pick a time for your call — one short form, then you're booked.

Assessment & book a call →
Step 3 · Get in touch · 45 min

Your call

We'll go through your situation together and decide, only then, what — if anything — makes sense as a next step.

This call is free. Any paid next step — like a Claim Check — comes only after, and only if it makes sense.