Quality that holds up
QMS built and remediated to ISO 13485 and 21 CFR 820 (QMSR) — design controls, CAPA, supplier quality, and audit readiness that survive inspection.
Combination products & medical devices
Complex products.
Complex products.
Quality you can prove.
DP Dynamic Solutions is a quality, risk, and statistics consultancy for combination products and medical devices. We build the quality systems, risk management, and statistical evidence your product depends on — with regulatory support when you need it.
Quality systems, risk management & statistical evidence — across the total product lifecycle.
Quality & risk
On track
ISO 13485 QMSDesign controls · CAPA
Certified
Risk Management FileISO 14971 · benefit-risk
Complete
Statistical AnalysisProcess capability · SAP
Validated
Combination Product21 CFR Part 4 cGMP
Aligned
98%audit-ready delivery
Quality · Risk · Data · Done Right
Four disciplines. One accountable partner.
Our name is our method. Every engagement is built on the same four foundations — so nothing critical gets missed between the drug and the device.
Risk you can defend
ISO 14971 risk management, human factors (IEC 62366), FMEA, and benefit-risk analysis that satisfy reviewers and protect patients.
Data with integrity
Study design, sample size, and statistical analysis — process capability, stability, and the evidence your claims stand on, with ALCOA+ data integrity throughout.
Execution to the finish
Advice means nothing without follow-through — systems built, findings closed, and evidence delivered. We stay until it's done.
What we do
Quality, risk & data services, end to end
Led by quality systems, risk management, and statistics — the disciplines that keep complex products compliant, defensible, and audit-ready.
Quality Management Systems
QMS build, gap assessment, and remediation to ISO 13485 and 21 CFR 820 (QMSR) — CAPA, internal audits, supplier quality, and inspection readiness that holds up.
Risk Management
ISO 14971 risk management files, FMEA facilitation (dFMEA / uFMEA / pFMEA), and benefit-risk analysis woven into your design and clinical evidence.
Statistics & Data Analysis
Study design, sample size, and statistical analysis plans — process capability (Cpk), MSA / Gage R&R, stability, and acceptance sampling, with ALCOA+ data integrity.
Design Controls & Human Factors
Design controls under the QMSR (ISO 13485 Clause 7.3), design and development files, and IEC 62366 usability engineering through human-factors validation.
Combination Product Quality
Integrated quality and risk across drug and device constituents under 21 CFR Part 4 cGMP — one coherent system, not two disconnected programs.
Regulatory Support
Support for your regulatory team — submission-readiness reviews, gap assessments, and the quality, risk, and statistical evidence that submissions depend on.
The DP difference
Combination products are where most programs stall.
A drug-device combination isn't two projects — it's one regulated system. We integrate quality, risk, and data across both constituents so nothing falls between them.
- One integrated quality system21 CFR Part 4 cGMP applied as a single, coherent QMS across both constituents — not two disconnected systems.
- Risk that spans the whole productISO 14971 risk management covering drug and device together, so combined-use hazards aren't missed.
- Evidence that holds upThe statistical and test data to support performance, stability, and combined-use claims.
- Design controls & human factorsDesign controls and usability that reflect how the whole product is actually used.
Combination product · anatomy
Drug / Biologic
Constituent part
Device
Constituent part
cGMP framework21 CFR Part 4
Quality systemIntegrated QMS
Risk fileISO 14971 (combined)
Data integrityALCOA+
How we work
A clear path from gap to audit-ready
No boilerplate. Every engagement follows a disciplined arc — so you always know where you are and what's next.
Assess
We map your product, quality system, and risk profile against the applicable standards — surfacing gaps early, while they're still cheap to fix.
Strategize
You get a clear quality and risk roadmap — priorities, evidence plan, and timeline — built to hold up under audit.
Execute
We do the work: quality systems, risk files, statistical analysis, design controls, and human factors — leading it or embedding directly with your team.
Sustain
Post-market surveillance, audit readiness, and change management keep you compliant long after launch.
25+
Years in medical device & combination-product quality
65+
QMS builds & remediations delivered
140+
Risk assessments & statistical analyses
100%
Engagements delivered audit-ready
Who we serve
Built for the hardest corners of medtech
Wherever a product touches both a therapy and a device, the regulatory questions get harder. That's exactly where we work.
Medical DevicesClass I–III, concept to clearance
Combination ProductsDrug-device & biologic-device systems
In Vitro DiagnosticsIVDs & companion diagnostics
Digital Health & SaMDSoftware as a Medical Device
Pharma & BiotechDevice constituents & delivery systems
Startups & Scale-upsFirst submission to first audit
About DP Dynamic Solutions
Advisors who understand both sides of the molecule
- 25+ years in medical device and combination-product quality, risk, and statistics.
- Hands-on with quality systems, risk management, and statistical analysis — not just slideware.
- Senior-level attention on every engagement — you work directly with the principal.
Our founding belief
Founder & Principal Consultant
DP Dynamic Solutions
"Combination products deserve advisors who understand both the drug and the device — and refuse to let anything fall between them."
Founder & Principal Consultant
DP Dynamic Solutions
DP Dynamic Solutions untangled a combination-product pathway we'd been stuck on for months. The strategy was clear, defensible, and — most importantly — it worked.
Let's talk
Let's get it done right.
Book a 30-minute consultation. We'll talk through your product, your pathway, and the fastest defensible route to market.
No obligation · Direct with a principal consultant