We build and scale health-tech ventures with precision.
Bonash BV partners with founders and operators to translate breakthrough ideas into regulated, manufacturable, and commercially ready products.
We bring hands-on experience from within the MedTech industry — combining engineering, regulatory, quality, and operational expertise to accelerate growth and reduce risk.
Bonash BV provides modular, hands-on support across the full MedTech value chain
from early development to regulatory clearance and commercial.
Medical device, bioscience and pharma
Establish compliant and scalable systems.
ISO 13485 implementation and internal audits
Technical documentation preparation
MDR and FDA 510(k) strategy and submissions
Clinical and operational strategy
Turn research into evidence that drives adoption.
Clinical trial design and coordination
Site selection and investigator onboarding
Data management and regulatory compliance
We help startups and growing companies navigate the complex path from innovation to market by combining strategic insight with operational execution
Based in The Hague, the Netherlands
Focus areas: spine, orthopedics, interventional, and digital health
Expertise across EU MDR and U.S. FDA pathways
Networked with KOLs, CROs, manufacturers, and distributors worldwide
We believe successful ventures are built on clarity, focus, and technical depth.
Our work blends strategy and implementation — helping teams establish regulatory systems, manage suppliers, design clinical studies, and prepare for international market entry.
We act as an extension of your team: practical, responsive, and driven by outcomes.
Operator-led – We’ve built and launched devices ourselves.
Outcome-driven – We set clear milestones and deliver measurable results.
Flexible – Available for projects, retainers, or fractional leadership.