HP

HP&M

Experienced Regulatory Expert

HP&M specializes in FDA regulatory consulting for medical device companies, providing expertise in regulatory strategy, premarket submissions, quality systems, risk management, and US agent representation.

Experience: 7+ years

Submissions: 15 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe Novo

Device Specialties

General HospitalCardiovascularNeurologyOrthopedic

Executive Summary

Professional Overview

HP&M specializes in FDA regulatory consulting for medical device companies, providing expertise in regulatory strategy, premarket submissions, quality systems, risk management, and US agent representation.

Core Specializations

Regulatory Pathways

510kDe Novo

Device Specialties

General HospitalCardiovascularNeurologyOrthopedic

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: 7+ years of regulatory experience.

Cruxi view

The job posting indicates that HP&M is seeking an experienced regulatory expert. Without further information, it's difficult to assess specific strengths.

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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