Quality Control in Medical Devices - Thematic Intelligence

Quality Control in Medical Devices - Thematic Intelligence

Summary

Medical devices regulations are ever-changing

The last couple of years has changed the regulatory landscape for medical devices. Regulatory requirements have undergone major changes all over the world, and the ability to navigate these changes is the key to success. Quality control for medical devices includes both a pre-market stage (to obtain regulatory approval) and a post-market stage (to ensure safety and efficacy in a larger test population). Proper navigation of all stages of quality control will continue to be critical to the success of a medical device.

As old regulations are replaced with new ones, and devices are assessed according to new standards, certain medical devices could face barriers in maintaining or gaining market approval.

While the COVID-19 pandemic has changed the medical device landscape in many ways, it has also caused some of the previously mentioned barriers by halting clinical trials and pausing certain medical procedures, which in turn resulted in fewer approvals and also less demand for certain devices.

Scope

  • This report is a thematic brief, which identifies those companies most likely to succeed in a world filled with disruptive threats. Inside, we predict how each theme will evolve and identify the leading and disrupting companies.
  • The report covers the Quality Control theme.
Reasons to Buy
  • GlobalData’s thematic research ecosystem is a single, integrated global research platform that provides an easy-to-use framework for tracking all themes across all companies in all sectors. It has a proven track record of identifying the important themes early, enabling companies to make the right investments ahead of the competition, and secure that all-important competitive advantage.
  • Develop and design your corporate strategies through an in-house expert analysis of quality control by understanding the primary ways in which this theme is impacting the medical devices industry.
  • Stay up to date on the industry’s major players and where they sit in the value chain.
  • Identify emerging industry trends to gain a competitive advantage.


  • Executive Summary
  • Players
    • Table Figure 1: Who are the regulatory bodies in each region?
  • Thematic Technology Briefing
    • Classifying medical devices
      • Table Thematic Technology Briefing
    • Medical Device Single Audit Program
    • ISO13485
    • The European Union In Vitro Diagnostics Regulation
  • Trends
    • Key trends
      • Table Key trends
    • Regulatory trends
      • Table Regulatory trends
  • Industry Analysis
    • Medical device approvals
      • Table Figure 2: Estimated number of medical devices by stage of development in 2022
    • Geographical analysis
      • Table Figure 3: Device classification by pipeline products in North America and Europe
      • Table Figure 4: Top 10 territories by pipeline product in Asia-Pacific
    • Therapy area analysis
      • Table Figure 5: Number of pipeline medical devices by therapy area
      • Table Figure 6: Top therapy areas by pipeline product
    • Social media trends
      • Table Figure 7: Top mentions on social media in the quality control theme
    • Timeline
      • Table Figure 8: The medical device regulatory story
    • The impact of COVID-19 on medical device regulations
      • The FDA’s emergency use authorizations for COVID-19
      • Health Canada’s proposed changes to the Medical Device Regulations
      • The delay of the Medical Device Regulations
  • Glossary
    • Table Glossary
  • Further Reading
    • GlobalData reports
      • Table GlobalData reports
  • Our thematic research methodology
    • Table Figure 9: Our five-step approach for generating a sector scorecard
  • About GlobalData
  • Contact Us

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