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Lachman Consultant Services, Inc.

Lachman Consultants provides expert-level compliance and regulatory services for medical devices, specializing in areas such as cardiology, orthopedics, and in vitro diagnostics. They also offer guidance for combination devices like auto-injectors and patch delivery systems, as well as Software as a Medical Device (SaMD). Their extensive expertise ensures clients experience the highest quality and...

Experience: 25+ years

Submissions: 120 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe NovoBreakthrough DevicesHumanitarian Device ExemptionIde

Device Specialties

CardiovascularGeneral SurgeryNeurologyRadiologyDental

Executive Summary

Professional Overview

Lachman Consultants provides expert-level compliance and regulatory services for medical devices, specializing in areas such as cardiology, orthopedics, and in vitro diagnostics. They also offer guidance for combination devices like auto-injectors and patch delivery systems, as well as Software as a...

Core Specializations

Regulatory Pathways

510kDe NovoBreakthrough DevicesHumanitarian Device ExemptionIde

Device Specialties

CardiovascularGeneral SurgeryNeurologyRadiologyDental

Services Offered

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: 25+ years of regulatory experience.

Cruxi view

Lachman Consultants provides compliance and regulatory services for medical devices, including combination products and SaMD. They offer expertise in areas such as cardiology, orthopedics, and in vitro diagnostics.

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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