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  5 Key Features of FDA Draft Guidance for Predetermined Change Control Plans (PCCPs) for Medical Devices

  Predetermined Change Control Plans (PCCPs) Draft Guidance with Implications for Medical Device Manufacturers and regulatory framework

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  How eLearning and LMS Empower Medical Device Employees

  elearning and LMS improve an employee’s ability to learn and adhere to the company QMS for medical device design and development.

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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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  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)”.

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  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.

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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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  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.

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  Gender Equity in Medical Devices: Bridging the Data Gap

  Gender data gap’s implications on women’s health and strategic measures for its integration into gender gap medical devices, regulatory frameworks and design processes.

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