Quick Starter Package

Feasibility study and roadmap for your medical device

From the idea to an MDR-compliant roadmap for your medical device. In 5 steps to a well-founded go or no-go decision: regulatory validated, realistically calculated, marketable.

Feasibility study for medical devices instead of expensive misguided development

You have an idea for a medical device or IVD and ask yourself the crucial questions before product development: Is it technically feasible? Is it compliant with MDR or IVDR? How will it reach the market?

This is exactly where YOOme Group’s Quick Starter Package comes in. In just a few weeks, we will examine your idea in a structured manner using a tried-and-tested 5-stage process, from an inventory to a feasibility and risk analysis in accordance with ISO 14971 to a validated roadmap for development, approval and production.

We combine your vision with interdisciplinary expertise in medical device development, regulatory affairs and life cycle management. The result is a resilient, investor-ready decision-making framework for financing rounds, development partners or your go or no-go decision.

Quick Starter Package for MedTech start-ups,
spin-offs and SMEs

5 steps to a feasibility study and MedTech roadmap

With the Entry Package or Full Package from YOOme, you can tackle this process step by step with experienced experts at your side.

Entry Package

Full Package

Quick Starter Package costs:
Fixed price for your feasibility study

12.000 €

Entry Package

Steps 1 to 3.
Analysis, initial feasibility assessment and interim feedback.

INCLUDES
+Assessment & target setting
+Feasibility & risk analysis
+Interim feedback & fine-tuning

OR

19.500 €

Full Package

All 5 steps including roadmap, final report and recommendations for the next phase.

INCLUDES EVERYTHING FROM ENTRY, PLUS
+Concept development & validation
+Full development roadmap
+Detailed final report
+Optional financing preparation

Your YOOme experts

YOOme consists of the teams of BAYOOCARE (Legal Manufacturer), BAYOOMED (Medical Software), Mechatronic Medical Engineers (Development & Manufacturing), Puls Product Design (Product Design & UX) and UID (User Interface Design). All YOOme partners are part of the 350-strong BAYOONET Group and have realized numerous joint projects, developed medical products and marketed them internationally.

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