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MEDINSIGHT TECHNOLOGIES, LLC — 510(k) & PMA Consultant (Neurology/Cardiovascular)

Regulatory Consultant

Regulatory Affairs Consultant with deep expertise in FDA submissions, PMA lifecycle management, IDE support, combination products and global regulatory compliance. Experienced in leading cross-functional teams, accelerating complex submission timelines, and developing high-quality regulatory documentation. Brings a strong blend of high-level industry leadership and consulting with a proven record ...

Experience: 15+ years

Submissions: 4 510(k), 3 PMA

Expertise & Specializations

Regulatory Pathways

510(k)PMADe NovoQ-SubIDE

Device Specialties

NeurologyCardiovascularRadiologyGastro UrologyWearable Digital

Regions Served

MEDINSIGHT TECHNOLOGIES, LLC provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)Canada (Health Canada)Middle East & AfricaLatin AmericaAsia-Pacific

Credentials & Recognition

Professional Experience

Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

Regulatory Affairs Consultant with deep expertise in FDA submissions, PMA lifecycle management, IDE support, combination products and global regulatory compliance. Experienced in leading cross-functional teams, accelerating complex submission timelines, and developing high-quality regulatory documen...

Core Specializations

Regulatory Pathways

510(k)PMADe NovoQ-SubIDE

Device Specialties

NeurologyCardiovascularRadiologyGastro UrologyWearable Digital

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
FDA Mock Audit
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.
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: US, EU, CA, MEA, LATAM, APAC
  • Background: 15+ years of regulatory experience.

Cruxi view

With 15 years of experience blending high-level industry leadership and consulting, this expert brings a rare strategic perspective to medtech regulatory affairs. Their value is most pronounced in their proven ability to navigate the most complex regulatory landscapes, demonstrated by their experience with high-risk Class III devices, PMA lifecycle management, and combination products. They possess deep technical competency in modern technologies like SaMD, AI/ML, and implantables across key clinical areas such as cardiovascular and neurology. For medtech companies, this translates into a partner who can not only author a submission but can strategically accelerate market access for innovative products on a global scale, ensuring compliance from initial concept through post-market surveillance.

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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