RA

Regulatory Compliance Associates

Medical Device Consultant

Regulatory Compliance Associates is a dedicated FDA regulatory consulting firm specializing in medical device companies. Their expertise encompasses comprehensive regulatory pathway assessment, robust ISO 13485 Quality Management System (QMS) consulting, and thorough ISO 14971 risk management.

Experience: 25+ years

Submissions: 75 510(k)

Expertise & Specializations

Regulatory Pathways

510kPmaDe NovoBreakthrough DevicesPre-Submission

Device Specialties

General HospitalCardiovascularNeurologyOrthopedicGastroenterology

Executive Summary

Professional Overview

Regulatory Compliance Associates is a dedicated FDA regulatory consulting firm specializing in medical device companies. Their expertise encompasses comprehensive regulatory pathway assessment, robust ISO 13485 Quality Management System (QMS) consulting, and thorough ISO 14971 risk management.

Core Specializations

Regulatory Pathways

510kPmaDe NovoBreakthrough DevicesPre-Submission

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: 25+ years of regulatory experience.

Cruxi view

Regulatory Compliance Associates specializes in guiding clients through all stages of the medical device consulting process, from product development to regulatory clearance/approval. They emphasize strict adherence to pre/post market information throughout a device’s life cycle.

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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