Regulatory & Quality Solutions for
Medical Device Start-Ups
For a medical device start-up, speed is everything - but building without a regulatory and quality roadmap turns that speed into risk. A single misstep in strategy or documentation can cost you months of runway and stall your next funding round.
At BioVision, we embed regulatory strategy into every stage of your product's lifecycle, delivering the elite-level regulatory and QMS compliance scaled to your timelines and budgets.
Here's how we accelerate your path to global market clearance:
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Investor-Ready Regulatory Strategy
We define your device's intended use, identify the right predicate devices, and map the fastest, most cost-effective route to clearance. The result is a defensible regulatory plan with predictable milestones and accurate budget forecasting - exactly what venture capitalists and grant committees (including the Israel Innovation Authority) need to fund your vision with confidence.
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Embedded QA/RA Management
Not ready for a full-time executive hire? Our senior consultants integrate directly into your team as your fractional QA or RA Manager. Working within a "Dual-QMS" framework, we run day-to-day compliance, lead internal audits, and author your regulatory files inside your own systems - so you get executive-level oversight without the executive-level headcount.
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End-to-End FDA Submissions
We manage your entire U.S. submission through the mandatory eSTAR platform, with successful FDA clearances. Our experience spans Pre-Submissions (Q-Subs), Traditional and Special 510(k)s, De Novo classifications, and Premarket Approvals (PMA).
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EU MDR CE Marking & Technical Documentation
We build bulletproof Annex II and Annex III Technical Documentation that stands up to European Notified Body scrutiny. Our experts author robust Clinical Evaluation Reports (CERs), complete General Safety and Performance Requirements (GSPR) mappings, and manage your EUDAMED onboarding.
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Audit-Ready QMS Establishment
We build and implement right-sized Quality Management Systems from the ground up — lean enough to move fast, robust enough to pass inspection. Every architecture is fully compliant with ISO 13485:2016 and the newly enforced FDA Quality Management System Regulation (QMSR).
Ready to build with confidence?
Let's map your regulatory strategy before your next milestone.
Contact us / Schedule a consultation