Easy13485 Makerspace · Capability

Train as you build. Comply as you grow.

Competence built into your company from day one — keeping your team qualified and audit-ready for every inspection. Don't bolt e-learning on later. Start right and grow with the training.

Sign in to the Academy

What the Academy offers

Knowledge and audit evidence, automatically.

Your built-in training system: role-based micro-courses, tracking and certificates — including the evidence auditors actually want to see. No extra effort.

Role-based

Role-based trainings

Clear rights and obligations under ISO 13485 and the MDR, so every role stays qualified and compliant.

For startups

Process trainings for startups

Go from idea to documentation with guided templates — so consulting goes where it has the most impact.

Expert

Expert trainings

Deep-dives across Quality Management, Regulatory Affairs, Risk Management and more.

Did you know?

MDR Article 10(9): staff must be trained, competent and documented.

Manufacturers are obliged to ensure all relevant staff are trained, competent and documented in their QMS responsibilities. Many teams overlook this early — and pay for it in costly, last-minute fixes before audits.

Take the Manufacturer Obligations Assessment

Role-based training

Role-specific and practical.

Structured, hands-on qualification for all key roles in an ISO 13485 and MDR-compliant QMS — from CEO and QMR to R&D, Risk, Clinical, Regulatory, Manufacturing, IT and Cybersecurity. Optimized for Easy13485, and usable as proof of basic competence for any ISO 13485 QMS.

Role-specific

Tailored to a concrete role

Each training focuses on real responsibilities, regulatory expectations and day-to-day execution — with examples and knowledge checks.

Audit-ready

Documented competence

Built-in tests, completion tracking and certificates create the documented competence auditors expect to see — without extra tools or manual follow-up.

Accessible

Accessible and flexible

Free for Easy13485 subscribers, students and interested professionals. Provided in German, completable in English via browser translation.

Explore the role trainings

PLC trainings

The whole product lifecycle, step by step.

The Easy13485 PLC training covers the entire product lifecycle and builds the foundation for your Technical Documentation in line with MDR Annex II. Instead of abstract theory, it guides you through every development phase — so consulting focuses on high-impact decisions, not basic regulatory orientation.

01

Plan Development

Define scope, strategy, intended use and regulatory context.

02

Define Design Input

Translate requirements, risks and user needs into design inputs.

03

Develop Product

Structured development across disciplines — from concept to design outputs.

04

Verify Product

Ensure design outputs meet defined inputs with traceable evidence.

05

Validate Product

Demonstrate fitness for intended use and clinical relevance.

06

Design Transfer

Prepare manufacturing, handover and controlled release.

07

Maintain & Update

Change control, post-market feedback and continuous improvement.

Together these phases form the backbone of your Technical Documentation — from intended use to Declaration of Conformity. The PLC process training is exclusively available to Easy13485 customers.

Explore the PLC trainings

Expert webinars

Stay informed.

Our webinars focus on topics MedTech teams are expected to understand — and demonstrate — in audits. From risk management to mandatory role-based trainings, each session turns regulatory requirements into practical, immediately usable guidance.

Risk Management

ISO 14971 in practice

Build a usable risk management file, link it to design decisions and present evidence auditors accept.

Mandatory

Required MedTech competencies

Webinars covering compliance-critical roles such as Medical Device Consultant and others.

Audit-focused

Practical, not theory-only

Each webinar is built around real audit expectations, common findings and clear takeaways.

Company training portal

Want all training in one place?

We can host a dedicated portal for your company, where your internal process trainings live next to the Easy13485 QMS trainings — so onboarding, role qualification and company-specific SOP training run on one platform with tracking and proof.

One record

One platform, one training record

Combine QMS training with your own SOP and process training — consistent tracking, certificates and audit-ready evidence in one system.

Onboarding

Faster onboarding, fewer gaps

New team members follow a clear learning path: role basics, process training and required competence — without missing critical steps.

Controlled

Company-specific, fully controlled

You decide content, structure and access. Keep training aligned with your procedures while staying compatible with ISO 13485 expectations.

You decide

Start smart. Choose how to begin.

A simple entry into professional compliance and quality management for startups — pick the path that fits where you are.

Start free

Start your MedTech Journey

Build the right foundation: Manufacturer Obligations Assessment, certificate on completion, and a first consulting call included — free.

Start the free e-learning
Direct

Direct consulting

Start immediately with tailored expert support. First consulting, 120 € (45 min), no prerequisites — startup-focused, practical guidance.

Book a consulting call
Train as You Build
Comply as You Grow.

We build competence into your company’s DNA from day one — keeping your team qualified and audit-ready for every inspection.

Don’t bolt e-learning on later — start right, grow with training.

Sign in to the Academy
What the Academy
offers

The Academy is your built-in training system: role-based micro-courses, tracking, and certificates — including the evidence auditors actually want to see.
Knowledge + audit evidence, automatically. No extra effort.

Role-Based Trainings

Clear rights and obligations under ISO 13485 and MDR so every role stays qualified and compliant.

Process Trainings for Startups

Go from idea to documentation with guided templates — bring in consultants only at high-impact steps

Expert Trainings

Deep-dives across Quality Management, Regulatory Affairs, Risk Management, and more.

Did You Know?

Under EU MDR Article 10(9), manufacturers are obliged to ensure all relevant
staff are trained, competent, and documented in their QMS responsibilities.
Many teams overlook this early — leading to costly, last-minute fixes before audits.

Want to know your exact obligations as a manufacturer under Article 10 & 16?

Take the Short Manufacturer Obligations Assessment
Role - Based Trainings

Easy13485 Role-Based Training provides structured, hands-on qualification
for all key roles in an ISO 13485 and MDR-compliant QMS.
Each role focuses on real responsibilities, regulatory expectations,
and day-to-day execution — supported by examples, knowledge checks,
and certificates that create audit-ready evidence.
While optimized for IPP Easy13485, all qualifications can also be used
as proof of basic competence for any ISO 13485 QMS.

Explore the Role Trainings

Role-specific & Practical

Each training is tailored to a concrete role —
from CEO and QMR to R&D, Risk, Clinical, Regulatory,
Manufacturing, IT, and Cybersecurity.

Audit-ready evidence

Built-in tests, completion tracking, and certificates create documented competence auditors expect to see — without extra tools or manual follow-up.

Accesible & flexible

Free for Easy13485 subscribers, students, and interested professionals.
Courses are provided in German and can be completed in English
using browser translation.

PLC - Trainigns

The Easy13485 PLC Process training covers the entire product lifecycle and provides the foundation for your Technical Documentation in line with MDR Annex II. Instead of abstract theory, the courses guide you step by step through every development phase — reducing the need for external consulting just to understand basic regulatory tasks.

Plan Development

Define scope, strategy, intended use, and regulatory context.

Define Design Input

Translate requirements, risks, and user needs into design inputs.

Develop Product

Structured development across disciplines — from concept to design outputs.

Verify Product

Ensure design outputs meet defined inputs with traceable evidence.

Validate Product

Demonstrate fitness for intended use and clinical relevance.

Design Transfer

Prepare manufacturing, handover, and controlled release.

Maintain & Update Product

Change control, post-market feedback, and continuous improvement.

Together, these phases form the backbone of your Technical Documentation — from intended use to Declaration of Conformity. The PLC process training is exclusively available to IPP Easy13485 customers.
Explore the PLC-Process Trainings

Expert - Webinars

Stay Informed

Our webinars focus on topics MedTech teams are expected to understand – and demonstrate – in audits. From Risk Management to mandatory role-based
trainings, each session translates regulatory requirements into
practical, immediately usable guidance.

Risk Management

Practical sessions on ISO 14971 — how to build a usable risk management file,
link it to design decisions, and present evidence that auditors accept.

Mandatory MedTech Trainings

Webinars covering required competencies such as Medical Device Consultant and other compliance-critical roles.

Audit-focused & practical

No theory-only sessions. Each webinar is built around
real audit expectations, common findings, and clear takeaways.

Company - Trainings Portal

Want all training in one place?

We can host a dedicated portal for your company where your
internal process trainings live next to the Easy13485 QMS trainings — seamlessly.
That means onboarding, role qualification, and your company-specific SOP training run on
one platform with tracking and proof.

One platform, one training record

Combine QMS training with your own SOP and process training — with consistent tracking,
certificates, and audit-ready evidence in one system.

Faster onboarding & fewer gaps​

New team members follow a clear learning path: role basics, process training, and required competence — without missing critical steps.

Company-specific, fully controlled

You decide the content, structure, and access. Keep your training aligned with your
procedures while staying compatible with ISO 13485 expectations.

Capabilities
Easy13485 Journey

📄

Evidence

Claims, development and evidence — traceable from day one.

💻

Easy Expert

AI-supported access to Easy13485 roles, processes and templates.

🎓

Academy

Role-based training with documented competence.

⚙️

QMSaaS

A maintained QMS workspace for daily operation.

🧾

Readiness Audit

Checks, findings and audit-oriented preparation

OR

Contact us
You Decide

Start smart. Choose how you want to begin.

For startups, we offer a simple entry into professional compliance and quality management.

Start your Medtech Journey

Build the right foundation and get rewarded.

  • “16 Obligations of a Manufacturer” course
  • Certificate after completion
  • First consulting call included – free
  • Assessment for Claim Check
Start the free E-learning

Direct Consulting

Start immediately with tailored expert support.

  • First consulting
  • 120€ (45 min)
  • No prerequisites
  • Startup-focused, practical guidance
Book a Consulting Call (120 € / 45 min)
ipp.

Contact

  • Kerschensteinerstr. 79
    90471 Nürnberg
  • kontakt(at)ipp-nbg.com

Office hours

Monday to Friday
8:00 am - 2:00 pm