2023 Medical Device Quality Trends

4 Challenges and Opportunities You Need to Know

What does 2023 hold for the medical device industry? The U.S. Food and Drug Administration (FDA) and other regulators have great expectations for medical devices - and a lot of those will affect the quality department. Some of those include:

  • FDA ISO 13485 harmonization.
  • Medical device cybersecurity standards.
  • FDA medical device recalls.
  • Medical device compliance inspections.

What’s Next for the Medical Device Industry

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What is the future of the medical device quality industry?

Harmonization between regulations and standards can make compliance easier, but medical device companies will have to get to market and react faster in the future. This has to be done by digitizing.

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What are the biggest challenges faced by the medical device industry?

As medical devices become more connected, cybersecurity risk increases. Staying ahead of hackers, following new guidance, and still being innovative present challenges for medical device companies.

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How is regulatory compliance changing for the medical device industry?

Compliance is increasingly dependent on how connected a medical device’s enterprise systems are. This is especially true when it comes to inspections where data must be provided at a moment’s notice.

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