MC

MCRA

FDA Regulatory Consultant

MCRA is a dedicated FDA regulatory consulting firm specializing in supporting medical device companies. With extensive expertise, they offer comprehensive guidance and implementation strategies for a wide range of FDA submissions, ensuring clients navigate the regulatory landscape effectively.

Experience: 15+ years

Submissions: 75 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe NovoPre-SubmissionIdePma

Device Specialties

CardiovascularOrthopedicGeneral SurgeryNeurologyGastroenterology

Executive Summary

Professional Overview

MCRA is a dedicated FDA regulatory consulting firm specializing in supporting medical device companies. With extensive expertise, they offer comprehensive guidance and implementation strategies for a wide range of FDA submissions, ensuring clients navigate the regulatory landscape effectively.

Core Specializations

Regulatory Pathways

510kDe NovoPre-SubmissionIdePma

Device Specialties

CardiovascularOrthopedicGeneral SurgeryNeurologyGastroenterology

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: 15+ years of regulatory experience.

Cruxi view

MCRA is a regulatory advisor for the medical device and biologics industries. They offer advice and implementation strategies for FDA submissions.

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

Contact MCRA

Share a brief overview of your device and timeline. Cruxi will forward your request to MCRA and help structure next steps.

Contact Now