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  FDA Guidance on Medical Device Cybersecurity Overview

  2024 FDA guidance on medical device cybersecurity covering risk management, design controls and software validation is explained in this article. Cybersecurity, Risk Management, Secure Product Development Framework (SPDF) are also covered.

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  5 Key Points in FDA’s Real-World Evidence Draft Guidance

  FDA Real-World Evidence Draft Guidance analysis identifies five key points to help understand the potential impact of the draft guidance.

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  Review of the FDA Selecting a Predicate Device to Support a 510(k) Submission Draft Guidance on Best Practices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

  Qualifying for FDA Medical Device Development Tools (MDDT) program, categories, history, benefits, CDRH Qualification and Decision Framework.

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  Avoid Common Medical Device Regulatory and QMS Hidden Costs

  Medical device regulatory and QMS hidden costs can often be avoided when projects are well defined early to understand and know the costs up front.

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