Quality
We build systems and documents that hold up under inspection — not binders that look good until an auditor opens them.
About the firm
Senior expertise. Straight answers. Done right.
DP Dynamic Solutions is an independent quality, risk, and statistics consultancy built for the products the big firms find too complicated — where a therapy and a device have to work, and be proven, as one.
Our story
Born from both sides of the molecule
Combination products fail reviews for a predictable reason: the drug team and the device team never truly worked as one. Requirements slip through the gap between them.
DP Dynamic Solutions was founded to close that gap. We bring senior quality, risk, and statistics expertise that spans both constituents — so the quality system, the risk file, and the data behind your claims all tell one coherent, defensible story.
No layers, no hand-offs to junior staff. You work directly with the principal who owns your outcome — from the first strategy call to the final audit.
"Good quality isn't paperwork — it's evidence. Get the systems and the statistics right, tell the story honestly, and compliance takes care of itself."
- 25+ years in medical device & combination-product quality
- QMS, risk & statistics across dozens of medtech programs
- Hands-on — systems and analyses, not just advice
What we stand for
Quality. Risk. Data. Done Right.
Four principles on the door — and the actual standard we hold every engagement to.
Risk
We surface risk early and manage it honestly, so decisions are made with eyes open and evidence in hand.
Data
Every claim traces to evidence. We design the studies, run the statistics, and tell you honestly what the data supports — before an auditor does.
Done Right
We finish what we start. Filed, closed, cleared — not a deck of recommendations left on your desk.
Depth of expertise
Fluent in the standards that govern your product
The standards, methods, and frameworks we work in every day.
ISO 13485 — Quality Management
21 CFR Part 820 / QMSR
ISO 14971 — Risk Management
FMEA — dFMEA / uFMEA / pFMEA
Statistical Methods — SAP · Sample Size · Cpk
MSA / Gage R&R & Process Validation
IEC 62366 — Usability Engineering
21 CFR Part 4 — Combination Products
Regulatory submission support (510(k) / PMA)
How an engagement runs
What working with us looks like
A predictable rhythm from first call to sustained compliance.
Step 01 · Discovery call
We listen first
A 30-minute conversation about your product, stage, and the pathway question keeping you up at night. No charge, no pitch.
Step 02 · Scoped proposal
A clear plan & price
You get a written scope with deliverables, timeline, and a fixed or retained fee — so there are no surprises later.
Step 03 · Execution
We do the work
Quality systems, risk files, statistical analysis, design controls, and human factors — led by the principal, with regular checkpoints and no junior hand-offs.
Step 04 · Sustained partnership
We stay in your corner
Post-market surveillance, audit readiness, and change management — so you stay compliant well beyond launch.
Let's talk
Bring us your hardest quality question.
The first call is free and genuinely useful. Book 30 minutes and leave with a clearer path than you came in with.
No obligation · Direct with a principal consultant