Clear and accurate quality and regulatory support for your medical device — from design controls to audit readiness and market authorization.
SpearHead Consulting exists to make quality and regulatory compliance a driver of market access — not a barrier to it.
We support medical device companies with clear, technically accurate guidance across the device lifecycle. No jargon walls, no black-box deliverables: you see exactly where you stand, what the risks are, and what happens next.
Whether you are building your first Quality Management System, preparing for an FDA inspection or Notified Body audit, or strengthening design controls, we work alongside your team to build compliance that lasts.
Precision in Regulation. Integrity in Innovation.
From design and development through submission, audit, and post-market — support at every stage of your device's life.
Honest assessments of your submissions, gaps, and risks — the picture your auditors will see, before they see it.
We embed with your team, transfer knowledge as we go, and leave you more capable than we found you.
The way we work matters as much as what we deliver.
Full visibility into your submissions, gaps, and risks. You always know where you stand — no surprises in front of an auditor.
Technical precision in every document, from design history files to regulatory submissions. Details are where audits are won.
Sustainable Quality Management Systems built to outlast the audit — solving root causes, not symptoms.
Global requirements translated into clear, actionable steps your team can actually execute.
Six focused practice areas covering the medical device lifecycle — engage one, or combine them into a complete compliance program.
The management oversight and technical clarity leadership teams need to navigate the medical device lifecycle — so decisions are made with a complete, accurate picture of quality and regulatory standing.
Discuss management supportAn audit should not be a source of anxiety.
We run mock audits and assessments that show you exactly what an FDA investigator or ISO 13485 Notified Body auditor will see — while there's still time to act on it.
Corrective and Preventive Actions are central to a healthy QMS. We help your organization move past symptom-fixing — identifying true root causes and implementing solutions that verifiably hold.
Strengthen your CAPA processQuality integrated into R&D from day one — with Design Controls and ISO 14971 risk management oversight that keeps innovation moving while building a submission-ready design history.
Support your design processYour Quality Management System and regulatory strategy are core business assets. We build and strengthen them around your device and your markets — not a one-size-fits-all compliance template.
Build your QMS and strategyYour suppliers are an extension of your quality system. We strengthen the relationship on both sides — qualifying the right partners and keeping their performance visible and controlled.
Control your supply chainEvery engagement follows the same disciplined logic we build into your QMS.
We review your current state — documentation, processes, and risks — and give you an honest, specific picture of where you stand.
You get a prioritized, actionable roadmap: what to fix first, what can wait, and what it takes to get there.
We work hands-on with your team to execute — building systems, documents, and habits that fit how you actually operate.
Objective evidence that it works: effectiveness checks, internal audits, and readiness reviews before anyone official arrives.
We work inside the standards your auditors audit against — so nothing gets lost in translation between regulation and reality.
Tell us where you are in your device lifecycle and what's keeping you up at night. We'll come back with clear next steps — and no jargon.
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