What services does Hiren Patel offer?

Hiren Patel offers Regulatory Pathway Assessment, Classification Assessment, Predicate Analysis, Test Strategy, 510(k) Authoring & Submission, RTA / Deficiency Support and other regulatory consulting support depending on project needs.

What pathways does Hiren Patel support?

Hiren Patel supports 510(k), Post-market and related FDA lifecycle activities.

What specialties does Hiren Patel work in?

Hiren Patel commonly supports IVD, Orthopedic, Wearable Digital, Other device areas.

What regions does Hiren Patel serve?

Regions served include: United States (FDA), European Union (MDR/IVDR).

How much regulatory experience does Hiren Patel have?

Hiren Patel has 12+ years in regulatory and quality work.

Hiren Patel — 510(k) & Post-market Consultant (IVD/Orthopedic)

Director of QA/RA

Highly accomplished QA/RA professional with over 12 years of extensive experience in the medical device industry, specializing in design, quality assurance, and regulatory support from concept to commercialization. Proven track record of successful product launches, including COVID diagnostics, orthopedic implants, catheters, and SaMD. Expertise in navigating complex regulatory pathways such as FD...

Experience: 12+ years

Expertise & Specializations

Regulatory Pathways

510(k)Post-market

Device Specialties

IVDOrthopedicWearable DigitalOther

Regions Served

Hiren Patel provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)

Credentials & Recognition

Education & Credentials

Possesses a Bachelor of Science in Biomedical Engineering from Florida International University, complemented by a Minor Concentration in Chemistry. This strong scientific foundation provides a deep understanding of the technical intricacies involved in medical device development and regulatory compliance. Their academic background equips them with the analytical and problem-solving skills essential for navigating complex regulatory challenges in the medtech industry.

Professional Experience

A highly accomplished Director of QA/RA with extensive experience leading quality and regulatory affairs for medical device companies from inception through commercialization. Proven success in launching complex products, including COVID diagnostics, orthopedic implants, and SaMD, while managing robust Quality Management Systems and ensuring audit readiness for global regulatory bodies such as the FDA, EU-MDR, and MDSAP. Demonstrated expertise in supplier quality, risk management, and the full product development lifecycle, consistently driving efficient project execution and achieving successful regulatory outcomes.

Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510(k)Post-market

Device Specialties

IVDOrthopedicWearable DigitalOther

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.

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
Background: 12+ years of regulatory experience.

Cruxi view

With 12 years of extensive experience, this QA/RA Director is a formidable asset for medtech companies seeking robust regulatory and quality assurance support. Their deep expertise spans the entire product lifecycle, from initial concept through commercialization, with a proven track record of successfully launching diverse devices including critical COVID diagnostics, orthopedic implants, and SaMD. Hiren Patel demonstrates exceptional proficiency in navigating complex global regulatory landscapes, specifically the US FDA QSR, EU-MDR, and MDSAP, making them invaluable for companies targeting both US and EU markets. Their technical competencies in QMS implementation, risk management (ISO 14971), and validation strategies (IQ/TMV/OQ/PQ/PPQ) ensure a strong foundation for compliance and product success, setting them apart as a comprehensive solution provider.

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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