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Strategic Intelligence: Quality Control and Regulation in Medical Devices (2025)

Publisher GlobalData
Published Aug 29, 2025
Length 33 Pages
SKU # GBDT20413247

Description

Strategic Intelligence: Quality Control and Regulation in Medical Devices (2025)

Summary

The medical device industry is highly regulated, with stringent requirements set by different regulatory bodies such as the FDA. Compliance with regulations is essential for ensuring product safety and efficacy, and quality control is not a one-time effort. It involves continuous improvement methodologies to enhance the quality of products over time.

Scope
  • Quality control ensures safety and efficacy of medical devices
  • Technological advancements in the medical field can impact regulations
  • Medical device regulation is increasingly shaped by a push and pull between global harmonization and regional divergence
Reasons to Buy
  • Understand how medical devices are regulated and classified
  • Understand how technology is impacting regulations now and in the future
  • Learn about the different trends that are impacting how different countries are regulating medical devices

Table of Contents

33 Pages
Executive Summary
Players
Thematic Briefing
Classifying medical devices
The Medical Device Single Audit Program
ISO13485
The EU In Vitro Diagnostics Regulation
Trends
Technology trends
Macroeconomic trends
Regional regulatory trends
Industry Analysis
Medical device approvals
Pipeline products regions and classification
Timeline
Sector Scorecard
Medical devices sector scorecard
Who’s who
Thematic screen
Valuation screen
Risk screen
Glossary
Further Reading
GlobalData reports
Our Thematic Research Methodology
About GlobalData
Contact Us
List of Tables
Table 1: Classifying medical devices
Table 2: The Medical Device Single Audit Program
Table 3: Technology trends
Table 4: Macroeconomic trends
Table 5: Regional regulatory trends
Table 6: Glossary
Table 7: GlobalData reports
List of Figures
Figure 1: Who are the regulatory bodies in each region?
Figure 2: Pipeline database development stage and product approval dates
Figure 3: Device classifications and territories
Figure 4: The medical device regulatory story
Figure 5: Who does what in the medical devices space?
Figure 6: Thematic screen
Figure 7: Valuation screen
Figure 8: Risk screen
Figure 9: Our five-step approach for generating a sector scorecard

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