Design and develop your next device — from concept through verification, validation, and design transfer. We bring decades of experience building Design History Files (Design and Development Files) that satisfy the regulatory requirements of your targeted regions of the world and all applicable international standards from day one.
The product development phase is where future regulatory and quality problems are either prevented or created. A DHF (DDF) that's built well from day one supports a clean 510(k) submission, complements the audit-readiness of a QMS, and facilitates an easily executed post-market program.
Our Principals have led product development inside medical device manufacturers — building Design History Files (Design and Development Files), running design reviews, executing V&V protocols, and managing design transfer to manufacturing. We bring that same rigor to every engagement.
We work alongside your engineering team — not as outside reviewers, but as embedded partners who help you design with regulatory and quality outcomes already in mind.
Plan, scope, and run product development programs against regulatory timelines and milestones.
Translate clinical or commercial needs into device requirements and architecture.
Iterative prototyping support with documented testing aligned to downstream V&V.
Build design control infrastructure that satisfies regulators and works for your team.
Design verification and validation plans, protocols, and reports built for review.
End-to-end risk management file including hazard analysis, risk evaluation, and benefit-risk analysis.
Biological evaluation planning per ISO 10993, with external lab selection and oversight.
Selection, engagement, and management of external testing labs for performance, biocompatibility, and other testing.
Build Design History Files (Design and Development Files) that satisfy FDA, EU MDR, and ISO 13485 expectations.
Bring legacy DHFs (DDFs) into compliance with current expectations for established and acquired products.
Transfer designs from development to manufacturing with documented process validation.
Design review facilitation, change control, and the documentation that regulators expect to find.
Schedule a no-cost consultation. We'll walk through where you are, what's needed, and how Novare can help you get there.
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