What services does de novo jury consulting offer?

de novo jury consulting offers Regulatory Pathway Assessment, 510(k) Submission Authoring, De Novo & PMA Strategy, QMS Setup & Implementation and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does de novo jury consulting specialize in?

de novo jury consulting specializes in 510k, De Novo, Pma and other FDA regulatory pathways for medical devices.

What is de novo jury consulting's regulatory experience?

de novo jury consulting has 7+ years of experience, 12+ 510(k) submissions in FDA regulatory affairs.

de novo jury consulting

Co-Founder & President

de novo jury consulting is a premier FDA regulatory consulting firm dedicated to guiding medical device innovators through complex regulatory pathways. Our expert team specializes in de novo classifications, 510(k) submissions, and Premarket Approval (PMA) strategies, ensuring a smooth and efficient journey from concept to market. We leverage deep industry knowledge and a proactive approach to hel...

Experience: 7+ years

Submissions: 12 510(k), 5 De Novo, 2 PMA

Expertise & Specializations

Regulatory Pathways

510kDe NovoPmaPost Market

Device Specialties

Ivd

Regions Served

de novo jury consulting provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)

Credentials & Recognition

Certifications

Regulatory Affairs Certified
RAPS
2017

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kDe NovoPmaPost Market

Device Specialties

Ivd

Services Offered

Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.

510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.

De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.

QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.

Post-Market Support
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.

Cruxi Independent Snapshot

Best suited for

• MedTech companies seeking expert regulatory guidance

Experience signals

Regions: US, EU
Background: 7+ years of regulatory experience.

Cruxi view

de novo Jury Consulting is a premier FDA regulatory consulting firm with deep expertise in guiding medical device innovators through complex regulatory pathways. With 7 years of experience, their team specializes in de novo classifications, 510(k) submissions, and Premarket Approval (PMA) strategies, having submitted 12 510(k) applications and handled 5 de novo applications. The firm's team has a strong background in In Vitro Diagnostics (IVD) and novel medical technologies, leveraging their knowledge to help clients achieve regulatory success. Their proactive approach and commitment to client success make them a valuable partner for medtech companies, particularly those seeking assistance with complex regulatory submissions. de novo Jury Consulting's regulatory expertise, FDA experience, and submission track record make them a top choice for medtech companies seeking to navigate the complex regulatory landscape.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

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