What services does Regulatory Compliance Associates (RCA) offer?

Regulatory Compliance Associates (RCA) 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 Regulatory Compliance Associates (RCA) specialize in?

Regulatory Compliance Associates (RCA) specializes in 510k, De Novo, Pma and other FDA regulatory pathways for medical devices.

What is Regulatory Compliance Associates (RCA)'s regulatory experience?

Regulatory Compliance Associates (RCA) has 25+ years of experience, 40+ 510(k) submissions in FDA regulatory affairs.

Regulatory Compliance Associates (RCA)

Medical Device Consultant

Regulatory Compliance Associates can help guide you through any stage of the medical device consulting process, with capabilities during product development through the regulatory clearance/approval of your product. They offer expertise in guiding clients through the medical device consulting process, ensuring adherence to pre/post market information throughout a device's lifecycle.

Experience: 25+ years

Submissions: 40 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe NovoPmaIdeQ Sub

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kDe NovoPmaIdeQ Sub

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

Background: 25+ years of regulatory experience.

Cruxi view

RCA offers medical device consulting services, guiding clients through product development and regulatory clearance/approval. They emphasize adherence to pre/post market information throughout a device's lifecycle.

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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