WHERE ARE YOU RIGHT NOW?
Idea
What are you building? Who will use it? What will you claim it does?
QUALITY · CLINICAL · REGULATORY
You have the idea.
We know what comes next.
Helping medical device, diagnostic, pharmaceutical and biotech companies turn promising ideas into regulated products.
Tell us what you're building ↗MEDICAL DEVICEDIAGNOSTICSPHARMABIOTECH
FROM CONCEPT TO COMMERCIALIZATION
A good idea is the beginning.
The path is what matters.
Regulated products succeed when the regulatory strategy, evidence, clinical work and quality system are built in the right order.
Path
Define the regulatory pathway, FDA expectations, product classification and evidence strategy before expensive work begins.
Evidence
Plan the testing, validation, risk management, clinical work, suppliers and documentation needed to support the product.
FDA
Prepare for the submission, 510(k), regulatory interactions, audits and questions that determine what happens next.
Market
Build the quality controls and operating discipline needed to launch, scale and remain compliant.
CAPABILITIES
One senior partner across the workstreams that have to agree.
01
FDA & Regulatory
Regulatory pathway assessment, 510(k) planning and submission support, predicate and comparison strategy, gap assessment, evidence planning and regulatory change assessment.
02
Clinical Trial Regulatory
Protocol and informed consent support, IRB coordination, study startup, amendments, site activation, vendor and laboratory coordination, sponsor-side oversight and study documentation.
03
Quality Systems
QMS design and remediation, CAPA, complaints, deviations, change control, training, document control, risk management and inspection readiness.
04
Supplier Quality & Audits
Supplier qualification, FDA and ISO-based audits, laboratories, contract manufacturers, critical suppliers, corrective action review and ongoing supplier oversight.
05
Product & Launch Quality
Validation strategy, supplier and manufacturing changes, software and connected-device quality, technology transfer, launch planning and commercialization support.
06
Fractional Leadership
Senior quality and regulatory leadership for organizations that need experienced judgment and execution without building the full function first.
FOUNDER / PRINCIPAL CONSULTANT
Experience matters when the decisions get expensive.
Ariane Davis brings more than a decade of experience across medical devices, pharmaceuticals, biotech, diagnostics, clinical research and regulated manufacturing.
Her work spans the regulated-product lifecycle: building quality systems inside industry, leading investigations and cross-functional programs, supporting FDA and clinical regulatory work, and independently evaluating suppliers and quality systems on behalf of major healthcare organizations.
That perspective matters. DQC can help leadership decide what needs to happen, why it matters, and how to get it done — then stay involved through execution.
PMPASQ CQAFDAISO 13485ISO 9001ISO/IEC 17025
THE DIFFERENCE
Strategy that understands execution.
Execution that understands the regulator.
Quality
Systems that support the product instead of becoming the product.
Clinical
Study operations and regulatory work designed around the evidence you actually need.
Regulatory
A pathway that informs development before time and money are committed in the wrong direction.
START HERE
Tell us what
you're building.
Whether you're at the idea stage, preparing for FDA, planning a clinical study or solving a quality problem, start with where you are now.