What services does ALKU offer?

ALKU 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 ALKU specialize in?

ALKU specializes in 510k, Pma, Ide and other FDA regulatory pathways for medical devices.

What is ALKU's regulatory experience?

ALKU has 5+ years of experience, 3+ 510(k) submissions in FDA regulatory affairs.

ALKU

Medical Device Consulting Experts

ALKU is a dedicated FDA regulatory consulting specialist for medical device companies. Their comprehensive services encompass ISO 13485 Quality Management System (QMS) consulting and essential regulatory support to ensure compliance and facilitate market access.

Experience: 5+ years

Submissions: 3 510(k)

Expertise & Specializations

Regulatory Pathways

510kPmaIdeDe Novo

Device Specialties

General HospitalCardiovascular

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kPmaIdeDe Novo

Device Specialties

General HospitalCardiovascular

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: 5+ years of regulatory experience.

Cruxi view

ALKU provides medical device consulting expertise in quality & compliance, technical engineering & validation, regulatory, clinical, & medical affairs, & software & technology. They deliver methodology and resources to ensure compliant, effective, & efficient execution of quality system requirements.

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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