What services does Petra TEGLAS offer?

Petra TEGLAS 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 Petra TEGLAS support?

Petra TEGLAS supports 510(k), PMA, IDE, Post-market and related FDA lifecycle activities.

What specialties does Petra TEGLAS work in?

Petra TEGLAS commonly supports IVD device areas.

How much regulatory experience does Petra TEGLAS have?

Petra TEGLAS has 3+ years in regulatory and quality work.

Petra TEGLAS — 510(k) & PMA Consultant (IVD)

Q: What regions does Petra TEGLAS serve?

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

Regulatory Affairs Consultant

Petra TEGLAS is a highly accomplished and strategic Regulatory Affairs Consultant with extensive experience in the medical device and IVD sectors. She excels in navigating complex global regulatory landscapes, including FDA and EU requirements, with a proven track record in lifecycle management, international submissions, and ensuring market compliance for critical products. Her expertise spans a ...

Experience: 3+ years

Submissions: 5 510(k), 1 De Novo, 2 PMA

Expertise & Specializations

Regulatory Pathways

510(k)PMAIDEPost-market

Device Specialties

IVD

Regions Served

Petra TEGLAS provides regulatory consulting services to clients in:

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

Credentials & Recognition

Education & Credentials

Holds a Master of Science in Biotechnology from MATE - Hungarian University of Agriculture and Life Sciences and a Bachelor of Science in Biotechnology from the University of Szeged, both US-equivalent to Master's degrees. Further enhanced expertise with a Certificate of Applied Data Science from MIT Professional Education, focusing on data science basics and Python coding. This strong academic foundation in life sciences and data analytics provides a robust understanding of complex biological and technological systems, crucial for navigating the regulatory landscape of advanced medical technologies.

Certifications

Certificate of Applied Data Science
MIT Professional Education

Professional Experience

A seasoned Regulatory Affairs Consultant with significant experience at leading organizations like Illumina Inc. and Roche Hungary. Demonstrated expertise in managing global regulatory submissions, lifecycle management for IVDs, and ensuring compliance with FDA and EU standards for critical products, including NGS-based oncology CDx. Proven ability to develop and implement innovative process improvements, such as change management automation bots and centralized onboarding platforms, significantly enhancing efficiency and reducing regulatory risk. Successfully led global on-market change assessment groups, ensuring continuous product availability and compliance across international markets.

Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510(k)PMAIDEPost-market

Device Specialties

IVD

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: 3+ years of regulatory experience.

Cruxi view

Petra TEGLAS is a highly strategic Regulatory Affairs Consultant with 3 years of dedicated experience in the medical device and IVD sectors, offering a robust foundation in navigating complex global regulatory landscapes, including critical FDA and EU requirements. Her expertise is particularly strong in lifecycle management, international submissions, and ensuring market compliance for advanced products like NGS-based oncology CDx, making her an invaluable asset for medtech companies. Petra distinguishes herself through a proven ability to implement innovative, efficiency-driving solutions, such as automation bots for process improvement and centralized onboarding platforms, which significantly reduce regulatory risk. Her comprehensive knowledge of regulatory pathways, including 510(k), PMA, and IDE, coupled with her specialization in IVDs, clinical chemistry, hematology, pathology, and SaMD, positions her as a go-to expert for companies seeking agile and confident global market access.

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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