Related Experiment Video
Updated: Jun 16, 2025

Rapid and Low-cost Prototyping of Medical Devices Using 3D Printed Molds for Liquid Injection Molding
Published on: June 27, 2014
More than red tape: exploring complexity in medical device regulatory affairs
Yu Han1, Aaron Ceross1, Jeroen Bergmann1,2
1Department of Engineering Science, University of Oxford, Oxford, United Kingdom.
Introduction:
This study investigates the complexity of regulatory affairs in the medical device industry, a critical factor influencing market access and patient care.
Methods:
Through qualitative research, we sought expert insights to understand the factors contributing to this complexity. The study involved semi-structured interviews with 28 professionals from medical device companies, specializing in various aspects of regulatory affairs. These interviews were analyzed using a mix of qualitative coding and natural language processing (NLP) techniques.
Results:
The findings reveal key sources of complexity within the regulatory landscape, divided into five domains: (1) regulatory language complexity, (2) intricacies within the regulatory process, (3) global-level complexities, (4) database-related considerations, and (5) product-level issues.
Discussion:
The participants highlighted the need for strategies to streamline regulatory compliance, enhance interactions between regulatory bodies and industry players, and develop adaptable frameworks for rapid technological advancements. Emphasizing interdisciplinary collaboration and increased transparency, the study concludes that these elements are vital for establishing coherent and effective regulatory procedures in the medical device sector.
Related Concept Videos
Drug Regulation
Drug Control Governance: Regulatory Bodies and Their Impact
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Methods of Documentation VI: Case Management Model
For example, a patient with a chronic...
Clinical Trials: Overview
Preclinical Development: Overview

