• 

  FDA Guidance on Computational Modeling and Simulation in Medical Device Submissions

  Summary of nine-step process for developing and assessing the credibility of CM&S for regulatory submissions in the FDA Guidance Document “Assessing the Credibility of Computational Modeling and Simulation (CM&S) in Medical Device Submissions (17th November 2023)”.

• 

  Bio Break: Laboratory Developed Tests vs. In Vitro Diagnostics

  Laboratory Developed Tests vs. In Vitro Diagnostics Joris van der Heijden and Nick Allan dive into FDA’s new regulations.

• 

  14 Ways to Increase Medical Device Speed to Market

  Speed to market is a crucial part of medical device success. Experts draw upon their experience with hundreds of medical device products for proven tips and recommendations that increase medical device speed to market without sacrificing safety or quality.

• 

  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.

• 

  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.

• 

  ESG Medical Device Impact

  Environmental, Social and Governance (ESG) Medical Device Impact tips to ensure that your products fulfill compliance obligations. Major buyers request ESG reporting from suppliers as new and revised regulations require supply chain attention.

• 

  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.

• 

  5 Key Points in FDA’s Real-World Evidence Draft Guidance

  FDA Real-World Evidence Draft Guidance analysis identifies five key points to help understand the potential impact of the draft guidance.

• 

  16 Most Important Traits and Skills to Medical Device Development  

  16 important traits and hard and soft skills that medical device experts identify as the most important to medical device development success. 

There are no posts to show