What services does Sharlin Consulting offer?

Sharlin 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 Sharlin Consulting specialize in?

Sharlin Consulting specializes in 510k, Pre-Submission, De Novo and other FDA regulatory pathways for medical devices.

What is Sharlin Consulting's regulatory experience?

Sharlin Consulting has 25+ years of experience, 75+ 510(k) submissions in FDA regulatory affairs.

Sharlin Consulting

FDA Regulatory Consultant

Sharlin Consulting is a dedicated FDA regulatory consulting firm specializing in supporting medical device companies through their regulatory journey. With extensive experience, they offer expertise in navigating complex FDA requirements.

Experience: 25+ years

Submissions: 75 510(k)

Expertise & Specializations

Regulatory Pathways

510kPre-SubmissionDe NovoPma

Device Specialties

CardiovascularNeurologyOrthopedicGastroenterologyUrology

Regions Served

Sharlin Consulting provides regulatory consulting services to clients in:

European Union (MDR/IVDR)

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kPre-SubmissionDe NovoPma

Device Specialties

CardiovascularNeurologyOrthopedicGastroenterologyUrology

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

Regions: EU
Background: 25+ years of regulatory experience.

Cruxi view

This consultant's value cannot be determined without further information from the website. The absence of an about section, services section, and LinkedIn profile limits the ability to assess their expertise and strengths.

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

Contact Sharlin Consulting

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

Contact Now