Daniel & Daniel Consulting, LLC

Clinical & Regulatory Strategy, FDA/CE Mark Submissions, Clinical Studies, and Quality Systems

Since 1985, we have guided medical device companies through all stages of US and EU medical device authorization from initial strategy through final clearance or approval.

Discuss Your Pathway

Daniel & Daniel Consulting, LLC

Clinical & Regulatory Strategy, FDA/CE Mark Submissions, Clinical Studies, and Quality Systems

Since 1985, we have guided medical device companies through all stages of US and EU medical device authorization from initial strategy through final clearance or approval.

Discuss Your Pathway

Daniel & Daniel Consulting, LLC

Clinical & Regulatory Strategy, FDA/CE Mark Submissions, Clinical Studies, and Quality Systems

Since 1985, we have guided medical device companies through all stages of US and EU medical device authorization from initial strategy through final clearance or approval.

Discuss Your Pathway

Daniel & Daniel Consulting, LLC

Clinical & Regulatory Strategy, FDA/CE Mark Submissions, Clinical Studies, and Quality Systems

Since 1985, we have guided medical device companies through all stages of US and EU medical device authorization from initial strategy through final clearance or approval.

Discuss Your Pathway

Who We Are

Daniel & Daniel Consulting, LLC has been helping small to medium size medical device Companies develop clinical and regulatory strategy, complete clinical studies as a CRO, and gain product 510(k) clearance, De Novo grant, and PMA approvals since 1985.

Over 4 decades our team has helped our clients obtain market authorizations for dozens of different devices with more than 100 FDA submissions, spanning IDE approvals, 510(k) clearances, De Novo grants, and PMA approvals across more than 20 distinct device categories. We submit dozens of Pre-subs (Q-Subs, SIRs, 513(g), etc.) each year with dozens of FDA video conference calls across multiple FDA divisions and departments.

Our clients are innovators, companies that design and build surgical and endoscopic robots, AI-powered diagnostics, implantable circulatory support devices, transoral and endoluminal devices, vascular closure platforms, and next generation SaMD systems among many others. We help clients provide leading edge technology to patients worldwide.

Initiate Strategy

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Expertise Domains

Our Three Core Practice Areas

Regulatory Affairs

From predicate identification and FDA negotiation through IDE, 510(k), De Novo, and PMA submissions — we manage the complete regulatory process in partnership with U.S. FDA, European Notified Bodies and Competent Authorities, Health Canada, and Japanese regulatory counterparts.

Clinical Research

As a full-service Clinical Research Organization (CRO), we design protocols, develop CRFs, submit to IRBs, manage trials, oversee EDC systems, and deliver final study reports. Every study is structured to satisfy FDA evidentiary requirements from the first protocol draft.

Quality Systems

We have designed, developed, implemented, and evaluated quality systems for more than 20 medical device companies. Our compliance-ready QMS templates — refined over decades of use — have withstood FDA inspections and Notified Body audits.

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Proven Distinction

What Sets Us Apart

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Nearly 40 years of continuous FDA regulatory and clinical practice.

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510(k) clearances for combination device/drug products

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PMA approval for implantable vascular closure devices requiring pivotal IDE clinical trials

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Full-service CRO: we design, manage, and report pre- and post-market clinical studies.

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Quality systems designed and implemented for 20+ medical device companies.

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510(k) clearances for AI/Deep Learning Software as a Medical Device (SaMD): ECG analysis, X-ray fracture identification, autonomous robotic motion and brain structure analysis

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De Novo grants for first-of-kind Robotic Assisted Surgical Devices (RASD) — novel classifications with no predicate

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100+ FDA authorizations across IDE, 510(k), De Novo, PMA pathways.

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FDA reversal of initial PMA classification to 510(k) for multiple product lines

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International approvals: Canadian Therapeutic Branch, CE Mark (European Union), Japanese Shonin

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Hundreds of Q-Sub, SIR, 513(g) submissions along with extensive informal interactions with FDA staff.

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Guest lecturer for Stanford University’s biomedical engineering program (10+ consecutive years), focusing on regulatory and clinical affairs.