We fuse engineering pragmatism with regulatory clarity. Easy13485 is a plug-and-play, cloud QMS-as-a-Service — complete with templates, eLearning, and expert support to get you audit-ready, faster.
The Regulatory 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.
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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.
Pre-built ISO 13485 with templates, roles, and workflows — audit-ready and startup-flexible.
Learn more →Role-based microlearning with tracking and certification — compliance meets enablement.
Explore courses →MDR/ISO templates with expert review — focused, clear, and submission-ready.
View templates →AI-powered guidance built on Easy13485 — instant answers and document automation.
See how it works →Internal audits, mock runs, and CAPA reviews — so the real one feels routine.
Get support →From concept to CE — we help MedTech teams accelerate market access with structure, clarity, and a pragmatic ISO 13485 framework.
Plan and appraise clinical data aligned with GSPR and PMCF expectations for clean submissions.
Run a conform ISO 1345 system with audit program, findings management, and CAPA coaching.
Structure DHF/TF with templates and reviews; identify gaps and build a submission-ready evidence set.
Operate your RA function end-to-end — submissions, NB interactions, change control, post-market.
Lead complex programs with realistic plans tied to regulatory milestones and verification evidence.
Plan and document validations per ISO/FDA expectations — models, statistics, and compliant records.
Map product and business to lean, scalable processes — reduce overhead without losing control.
Out-of-the-box ISO 13485 with templates, roles, eLearning, and guidance — audit-ready day one.
Define verification strategies and orchestrate V&V plans aligned to regulatory pathways.
The IPP team combines engineering depth and regulatory precision — helping startups bridge the gap between innovation and market approval. We believe compliance should enable progress, not slow it down.
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Selected partners shaping the next generation of MedTech. We help them move from idea to MDR-ready products with Easy13485 and pragmatic guidance.
caire.ai
Coreway
Breathment
“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.”
“Compliance without the cost spiral. EASY13485 made our Class I software conformity predictable and stress-free. Templates and the Academy gave us clean evidence, while keeping our burn low. That clarity gave partners and investors confidence from day one.”
“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.”
