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Marco Theobold

Director of Medical Device and Drug Services

Registrar Corp Industry Expert

Since joining Registrar Corp in 2009, Mr. Theobald supervises a department of 20 regulatory specialists providing FDA regulatory services for pharmaceuticals, medical devices, radiation emitting devices and cosmetics. Over the years, he has represented Registrar Corp several times at trade shows and conferences, including MEDICA, FIME, and the UDI Conference as well as presented multiple webinars on medical device and cosmetic requirements, which were attended by businesses around the globe.

Background

Mr. Theobald was born in Germany and holds a Ph. D. from the University of Giessen/Germany in Biology/Genetics. He has more than twenty years of experience in Regulatory Consulting, Technical Services, Customer Service, and Team Leading.

Latest from Author


93 Results
FDA Medical Device Product Listing: A Complete Guide to Compliance and Market Access

Learn what FDA medical device listing means, who must list, and how it supports compliance, tracking, and market access in the U.S.

FDA Regulation of Radiation-Emitting Electronic Products

Learn FDA requirements for radiation-emitting products, including reports, accession numbers, Form 2877, import rules, and performance standards.

FDA Medical Device Labeling: Requirements, Content, and Compliance Strategy

Explore FDA medical device labeling rules under 21 CFR 801 and 820.120, including required elements, formatting, QSR controls, and submission tips.

Understanding the FDA’s GUDID: A Guide to the Global Unique Device Identification Database

Understand FDA's GUDID system, UDI submission rules, and device labeler requirements for compliance with 21 CFR Part 830 and Part 801.

A Comprehensive Guide to FDA eMDR Compliance and Reporting

Learn how to comply with FDA eMDR requirements, streamline adverse event reporting, and integrate eMDR into your quality system for better oversight.

Device Master Files (MAFs): Regulatory Protection and Strategic Utility for Medical Device Manufacturers

Learn how Device Master Files support FDA submissions, protect trade secrets, and streamline approvals for device components and materials.


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