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.

Wat 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?

Role - Based Trainigns

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.

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 life cycle 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.

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
trainings, each session translates regulatory requirements into
practical, immediately usable guidance.

Risk Management

Practical sessions on ISO 14971 — how to build a usable risk file,
link it to design decisions, and present evidence 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.Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.

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, andrequired 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.

Discover - The Makerspace

⚙️

QMS-Service

Easy13485 combines the speed of an out-of-the-box solution with the flexibility to reflect each team’s specific setup.

🎓
Academy

Designed to develop high potentials—like top consulting firms—the Academy turns training into a strategic growth tool.

📄

Tech-Doc.

Consultants are used strategically, not permanently.

💻

Certificator.AI

Answers in seconds, so teams stay in flow and budgets stay lean.

🧾

Audit Support

Confidence on audit day—fewer findings, fewer costly loops.

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.

E-Learning & free Consulting call

Build the right foundation and get rewarded.

“16 Obligations of a Manufacturer” course
Certificate after completion
First consulting call included – free

Direct Consulting

Start immediately with tailored expert support.

First consulting hour: €162
No prerequisites
Startup-focused, practical guidance

ipp.

Contact

Office hours

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

Train as You Build Comply as You Grow.