What services does Sunita Teekasingh offer?

Sunita Teekasingh offers Regulatory Pathway Assessment, Classification Assessment, Predicate Analysis, Test Strategy, 510(k) Authoring & Submission, De Novo & PMA Strategy and other regulatory consulting support depending on project needs.

What pathways does Sunita Teekasingh support?

Sunita Teekasingh supports 510(k), PMA, IDE, Post-market, De Novo and related FDA lifecycle activities.

What specialties does Sunita Teekasingh work in?

Sunita Teekasingh commonly supports Cardiovascular, Neurology, IVD, Other device areas.

How much regulatory experience does Sunita Teekasingh have?

Sunita Teekasingh has 15+ years in regulatory and quality work.

Sunita Teekasingh — 510(k) & PMA Consultant (Cardiovascular/Neurology)

Q: What regions does Sunita Teekasingh serve?

Regions served include: United States (FDA), European Union (MDR/IVDR), Canada (Health Canada), Asia-Pacific.

Principal Consultant

Sunita Teekasingh is a highly accomplished Regulatory Affairs Strategy Director with over 15 years of comprehensive experience in leading global regulatory strategy for medical devices and IVDs. She has a proven expertise in navigating complex product portfolios (over 9,000 SKUs across 130+ geographies) and ensuring compliance in major markets including the U.S., EU, Canada, and Asia-Pacific. Suni...

Experience: 15+ years

Submissions: 58 510(k)

Expertise & Specializations

Regulatory Pathways

510(k)PMAIDEPost-marketDe Novo

Device Specialties

CardiovascularNeurologyIVDOther

Regions Served

Sunita Teekasingh provides regulatory consulting services to clients in:

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

Credentials & Recognition

Education & Credentials

Holds an MSc and a BSN, complemented by RN and CCRN certifications, demonstrating a strong foundation in nursing and advanced studies. This academic and clinical background provides a unique perspective on patient care and medical device efficacy, directly enhancing regulatory expertise in medical and IVD product development and compliance. The combination of advanced degrees and specialized certifications signifies a deep commitment to healthcare and regulatory science.

Certifications

Registered Nurse

Critical Care Registered Nurse

Professional Experience

A highly accomplished Regulatory Affairs Strategy Director with over 15 years of experience leading global regulatory strategies for medical devices and IVDs. Proven success in complex product portfolios, achieving over 58 FDA clearances with significantly faster-than-industry-average review times. Expertise spans strategic oversight for 510(k) submissions, IVDR compliance, and high-stakes crisis management, including recovering denied PMAs and resolving DOJ investigations. Adept at liaising with global health authorities and managing project teams to ensure compliance across major markets and protect company revenue.

Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510(k)PMAIDEPost-marketDe Novo

Device Specialties

CardiovascularNeurologyIVDOther

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, CA, APAC
Background: 15+ years of regulatory experience.

Cruxi view

With 15 years of experience specializing in medtech and IVD compliance, this consultant is uniquely valuable for their regulatory expertise depth in navigating complex product portfolios across 130+ geographies, including the U.S., EU, Canada, and Asia-Pacific. Their exceptional ability to develop and implement high-level strategies for 510(k) submissions, IVDR compliance, and high-stakes crisis management has led to 58 FDA clearances with significantly faster-than-industry-average review times. Their expertise spans strategic oversight for 510(k) submissions, IVDR compliance, and high-stakes crisis management, including recovering denied PMAs and resolving DOJ investigations. Additionally, they possess extensive knowledge of critical regulatory standards and demonstrate proficiency in developing robust quality processes, risk management frameworks, and compliance training programs. This combination of expertise, experience, and technical skills makes them an invaluable asset for medtech companies seeking regulatory excellence.

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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