What services does Lachman Consultants offer?

Lachman Consultants 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 Lachman Consultants specialize in?

Lachman Consultants specializes in 510k, De Novo and other FDA regulatory pathways for medical devices.

What is Lachman Consultants's regulatory experience?

Lachman Consultants has 20+ years of experience, 75+ 510(k) submissions in FDA regulatory affairs.

Lachman Consultants

Consultant

Lachman Consultants is a specialized FDA regulatory consulting firm dedicated to supporting medical device companies. Their extensive expertise covers cardiovascular, orthopedic, and in-vitro diagnostic devices. They possess particular proficiency in Software as a Medical Device (SaMD) and digital health products, offering comprehensive services including regulatory pathway assessment and ISO 1348...

Experience: 20+ years

Submissions: 75 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe Novo

Device Specialties

CardiovascularAnesthesiology

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kDe Novo

Device Specialties

CardiovascularAnesthesiology

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.

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: 20+ years of regulatory experience.

Cruxi view

Lachman Consultants offers compliance and regulatory services for medical devices, with expertise in cardiology, orthopedics, in vitro diagnostics, and combination devices. They provide consultation and guidance for monitoring and measuring systems and Software as a Medical Device (SaMD).

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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