Easy13485 gives MedTech startups a ready-to-use ISO 13485 QMS — templates, training, and expert guidance included. Get audit-ready while staying focused on building your product.
The easy13485 Makerspace is where
innovation meets compliance.
Built around our Easy13485 system, it gives MedTech startups
everything they need to turn prototypes into certified products —
faster, leaner, and audit-ready from day one.
Each pillar of the Easy13485 Makerspace is designed to give MedTech founders
the structure and acceleration they need — from the first idea to CE certification.
Together they form a lean regulatory framework that transforms compliance
into a driver of innovation, trust, and growth.
A pre-configured ISO 13485 system, individually tailored to each startup. Roles, SOPs, and approvals are in place immediately — startups are audit-ready from day one.
Easy13485 combines the speed of an out-of-the-box solution with the flexibility to reflect each team’s specific setup.
Technical documentation is embedded in the QMS, supported by structured MDR/ISO templates. Startups stay in the driver’s seat, while regulatory guidance is provided only when needed.
Consultants are used strategically, not permanently.
Scan the steps, open what you need, and see exactly what you get inside the Makerspace — and what outcome it creates.
Scope & Gap Analysis (done with you, not to you)
Align scope, owners, and the audit pathway in one session.
We define your MDR/ISO scope, assign owners, and lock the audit pathway. You leave the first session with a plan your team can execute immediately.
EASY13485 does the heavy lifting
Templates → tailored docs, fast approvals.
We plug in a ready-to-use ISO 13485 QMS (SOPs, matrices, records) and tailor only what’s specific to your product. Fast alignment, fast approvals.
Coaching rhythm + evidence every week
Coaching + continuous evidence creation.
We run a lightweight cadence: design decisions, supplier work, risks, training — all captured as audit-ready evidence as you build.
Mock audit → CAPA closure (~2 weeks)
Find gaps early, close CAPAs before NB.
We run a realistic internal audit, package your audit evidence, and close CAPAs before a Notified Body ever sees them.
Stage 1 & 2 → certificate
Stage 1 + 2 with coached findings closure.
We support you through Stage 1 and Stage 2, coach responses, and drive findings to closure so you reach certification fast and credibly.
The Easy13485 Makerspace is not a consulting program. It is a structured
system that guides you step by step toward audit readiness—developed
exclusively for Easy13485 customers and deliberately separated from
traditional IPP consulting services. If you want to build your quality
management system independently, correctly, and without detours, the
Makerspace is your starting point.
Start smart. Choose how you want to begin.
For startups, we offer a simple entry into professional compliance and quality management:
Build the right foundation and get rewarded.
Start immediately with tailored expert support.
“We moved from the decision to go with EASY13485 to CE mark in less than 5 months.
For our Class I product, the Makerspace provided exactly the structure and guidance we needed.
It wasn’t just fast — it was the quickest, safest way to start generating revenue.”
Philipp Emonds
Coreway, Class I
“With IPP’s support we achieved ISO 13485 certification in just 5 months.
The process was fast, structured, and completely transparent on costs.
For a Class IIa startup like ours, that speed is crucial for our medical device certification timeline.”
Baturay Yalvaç
· Breathment, Class I
“With IPP’s support we achieved ISO 13485 certification in just 5 months.
The process was fast, structured, and completely transparent on costs.
For a Class IIa startup like ours, that speed is crucial for our medical device certification timeline.”
Mohtadi Ben Fraj
· caire.ai, Class IIa start-up
Pick a few basics about your startup and product. The calculator recommends the right Easy13485 setup and shows a transparent monthly breakdown (excl. VAT) — so you can immediately understand what drives the price.
1) Medical Device
Choose what you’re building (SaMD/software, non-active device, medical-electrical system, custom-made device). This sets the typical compliance scope and documentation needs.
2) Number of Employees
Select your team size. For larger teams, additional “team blocks” may be added automatically, because roles, onboarding, and QMS workload scale with headcount.
3) Risk Class
Pick the MDR class (I–III). Higher classes typically mean more structure, stronger traceability, and earlier audit readiness.
4) Requirement
Choose your goal: Training tool (onboarding + documented training), QM Service (work immediately in an audit-ready QMS), or Own QMS (build/extend your own QMS based on Easy13485).
5) Add-ons (optional)
Enable AI Act, ISMS (ISO/IEC 27001), or individual trainings. The calculator updates instantly and shows what’s included vs. optional.
Select your setup to get a recommended solution and monthly price (excl. VAT).
