SP

Shahid Siddiqui, Ph.D.

Mentor and Coach in Drug and Device Development and Regulatory Affairs

Expert in Drug Discovery, Medical Devices (IVDR), and Regulatory Affairs with more than 15 years' experience in Neurobiology, AI, Bioinformatics, Machine Learning & Precision Medicine, Neurodegenerative and Infectious Disease, Immune-Oncology, Molecular Biology, Biochemistry, Cell Biology and Genetics, Analytical Techniques. CE marks, EUMDR. Highly collaborative scientist and have developed proto...

Experience: 22+ years

Expertise & Specializations

Regulatory Pathways

510kDe NovoPmaIdeQ Sub

Device Specialties

CardiovascularNeurologyRadiologyOrthopedicGeneral Surgery

Regions Served

Shahid Siddiqui, Ph.D. provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)Asia-Pacific

Credentials & Recognition

Certifications

Food & Drug Administration - eDRL -Drug Labeling Guidance Certificate
FDA
2024
Generic Drug Small Business Admin.
Food and Drug Administration USA
2024

Executive Summary

Professional Overview

Expert in Drug Discovery, Medical Devices (IVDR), and Regulatory Affairs with more than 15 years' experience in Neurobiology, AI, Bioinformatics, Machine Learning & Precision Medicine, Neurodegenerative and Infectious Disease, Immune-Oncology, Molecular Biology, Biochemistry, Cell Biology and Geneti...

Core Specializations

Regulatory Pathways

510kDe NovoPmaIdeQ Sub

Device Specialties

CardiovascularNeurologyRadiologyOrthopedicGeneral Surgery

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, APAC
  • Background: 22+ years of regulatory experience.

Cruxi view

Shahid Siddiqui, Ph.D. is a seasoned expert in medtech regulatory affairs, boasting an impressive 22 years of experience and a strong background in drug discovery, medical devices (IVDR), and regulatory affairs. With 15+ years of expertise in Neurobiology, AI, Bioinformatics, Machine Learning & Precision Medicine, he has developed protocols adhering to ICH and FDA guidelines, resulting in successful clinical trials (Phase I-III) and significant commercial successes. His experience in CE marks, EU MDR, and FDA regulations makes him a valuable asset for medtech companies navigating complex regulatory landscapes.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

Contact Shahid Siddiqui, Ph.D.

Share a brief overview of your device and timeline. Cruxi will forward your request to Shahid Siddiqui, Ph.D. and help structure next steps.

Contact Now