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  5 Key Features of FDA Draft Guidance for Predetermined Change Control Plans (PCCPs) for Medical Devices

  Predetermined Change Control Plans (PCCPs) Draft Guidance with Implications for Medical Device Manufacturers and regulatory framework

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  Starting Medical Device Projects on the Right Foot

  Four areas that can make or break a new medical device development project from the start. Experts identify actions and offer advice that helps ensure new medical device projects start on the right foot.

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  Medical Device Post-Market Surveillance Enhances Safety

  Medical device post-market surveillance (PMS) is important to identify and address potential safety issues and improving device performance. Article covers regulatory landscape, challenges, innovations and collaborative efforts.

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  Similarities and Differences between Medical Device 510(k) and CE Marking

  Understanding similarities and differences between Medical Device 510(k) and CE Marking regulatory pathways helps harmonize overall regulatory strategy.

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  4 Regulatory Trends to Watch In 2024

  Overview of 2024 Regulatory trends include QMSR, LDTs, FDA guidances, and timelines in the EU for MDR and IVDR.

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  5 Key Points in FDA’s Real-World Evidence Draft Guidance

  FDA Real-World Evidence Draft Guidance analysis identifies five key points to help understand the potential impact of the draft guidance.

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  10 Most Read New Medical Device Blogs in 2023

  Our 10 most read evergreen Medical Device Blogs of 2023 along with most read new Medical Device Blogs 2023 from our employee experts.

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  Using The FDA’s Best Practices for Selecting a Predicate Device

  Review of the FDA Selecting a Predicate Device to Support a 510(k) Submission Draft Guidance on Best Practices

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  Variations Between FDA and EU MDR Requirements for Clinical Investigations

  A look at some of the differences between FDA and EU MDR process and requirements for clinical investigations.

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