Senior guidance in stage gate development, ISO 14971 risk management, and FDA / EU MDR compliance — embedded in your team, without the cost of a full-time hire.
We start with the full program picture, then go deep where it counts — risk and product development are the two disciplines that make or break a submission.
The master service that holds everything together. We personally manage the entire project management aspect of your program, end to end — from design input through regulatory submission — acting as one senior team across engineering, quality, and regulatory functions, so nothing falls through the cracks between disciplines.
Build a defensible, living risk management file aligned to ISO 14971:2019 that regulators trust and your engineering team can actually use across the full product lifecycle.
Structure your program with a rigorous, auditable stage gate process that satisfies both internal governance and FDA / EU MDR design control requirements at every gate.
We build a compliance matrix specific to your device classification, intended use, and patient population — then execute against it gate by gate.
Every engagement is scoped by milestone — not billed by the hour. We join your eQMS, attend your design reviews, and ship deliverables your team owns permanently.
A 60-minute session to map your program status, identify regulatory risk, and determine the right engagement model for your stage.
A milestone-based scope structured as monthly retainer blocks, aligned to your gate schedule, device classification, and budget.
We join your eQMS, attend design reviews, and produce deliverables alongside your engineers — not in a separate silo.
At each gate we prepare full review packages, facilitate approvals, and deliver a complete transfer kit your team retains forever.
Most early and mid-stage device companies don't need a full-time regulatory executive. They need exactly the right expertise at the right development stage.
| Capability | Full-Time Hire | Consulting Firm | BitzTech — Fractional ✓ |
|---|---|---|---|
| Annual Cost | $220K–$340K fully loaded | $300–$500/hr, unpredictable | Fixed retainer $8K–$18K/mo |
| Regulatory Depth | Varies by hire | Junior staff often assigned | Senior team, every engagement |
| Availability | Full-time, often underutilized | Scheduled weeks out | On-demand within 24 hrs |
| Coverage | One discipline only | Siloed by department | RA, Quality & Design Controls in one |
| Continuity | Risk of turnover | New team per engagement | Same team, full lifecycle |
| eQMS Integration | Embedded by default | External to your system | Fully integrated in your eQMS |
Every engagement starts with a no-cost 30-minute discovery call. Tell us where you are in development and we'll tell you exactly how we can help.
30 min · No obligation · Proposal within 48 hrs
Covered by our standard NDA — your information is never shared.
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