J&

J&J

J&J is a dedicated FDA regulatory consultant with 10 years of experience, specializing in guiding medical device companies through complex regulatory pathways. They offer comprehensive expertise in regulatory compliance, quality management systems, risk management, and auditing.

Experience: 10+ years

Submissions: 15 510(k)

Expertise & Specializations

Regulatory Pathways

510kPre-SubmissionIde

Device Specialties

General HospitalCardiovascularNeurologyOrthopedicGastroenterology

Executive Summary

Professional Overview

J&J is a dedicated FDA regulatory consultant with 10 years of experience, specializing in guiding medical device companies through complex regulatory pathways. They offer comprehensive expertise in regulatory compliance, quality management systems, risk management, and auditing.

Core Specializations

Regulatory Pathways

510kPre-SubmissionIde

Device Specialties

General HospitalCardiovascularNeurologyOrthopedicGastroenterology

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
ISO 14971 Consulting
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.
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

  • Background: 10+ years of regulatory experience.

Cruxi view

This is a guide to regulatory consulting firms, not a profile of a specific firm. The strength lies in providing information to entrepreneurs to help them find the right partner to navigate regulatory compliance and accelerate their path to market.

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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