SafeLink Consulting
Consulting Firm
SafeLink Consulting is a specialized FDA regulatory consulting firm with 12 years of experience. We focus on providing expert guidance for medical device companies navigating the 510(k) regulatory pathway. Our services encompass comprehensive quality system (QMS) support and detailed 510(k) guidance, ensuring successful clearance for Class I and Class II devices, particularly within the general ho...
Experience: 12+ years
Submissions: 10 510(k)
Expertise & Specializations
Regulatory Pathways
Device Specialties
Executive Summary
Professional Overview
SafeLink Consulting is a specialized FDA regulatory consulting firm with 12 years of experience. We focus on providing expert guidance for medical device companies navigating the 510(k) regulatory pathway. Our services encompass comprehensive quality system (QMS) support and detailed 510(k) guidance...
Core Specializations
Regulatory Pathways
Device Specialties
Services Offered
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
Cruxi Independent Snapshot
Best suited for
- • MedTech companies seeking expert regulatory guidance
Experience signals
- Background: 12+ years of regulatory experience.
Cruxi view
SafeLink Consulting offers 12 years of experience specializing in FDA 510(k) regulatory consulting, focusing on guiding medical device companies through the 510(k) clearance process. Their expertise lies in quality management systems (QMS) and 510(k) submissions for Class I and Class II devices, particularly within the general hospital specialty. This focused approach allows them to provide targeted and efficient support for companies seeking to navigate the FDA's regulatory landscape for these specific device types. Their fixed-project pricing structure offers predictability and cost control for clients.
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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