• 

  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.

• 

  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)”.

• 

  12 Steps to Set up a Biomed Lab

  Opening a biomed lab includes managing multi-layer organizational involvement all the way from facilities to the head of operations. When starting a new lab from scratch, the first step is to fully understand the organization’s mission and business goals. This will impact how you approach setup and any purchasing decisions you make. This article describes 12 essential steps to set up a biomed lab.

• 

  Medical Device Optical Breadboard Prototype Tips

  Tips for building a medical device optical breadboard prototype. When designing a medical device made of complex, multi-functional mutually interacting subsystems it’s best to de-risk those subsystems instead of coming up with a paper design, assembling it, and hoping it works first time. De-risking individual subsystem behaviours one at a time enables more-focused assessments and improves troubleshooting.

• 

  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.

• 

  Commercializing Medical Devices with Optics

  Engineers, regulatory, manufacturing and optics experts share their experiences and lessons learned commercializing hundreds of medical devices with optics components and interacting with optics engineers.

• 

  A Comparison of Detection and Imaging Methods Used in Optical Coherence Tomography

  This article discusses types of OCT and some of the imaging techniques they use, with a brief overview of some advantages and disadvantages of each. The most common medical uses of OCT are in ophthalmology and optometry, in which OCT is commonly used to take cross-sectional or 3D scans of the eye’s anterior and posterior segments. Other areas of include dentistry, dermatology, and gastroenterology.

• 

  The Value of SBOMs and SBOM Analysis

  SBOM Analysis and Value covers the FDA “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance, role of Software Bills of Materials (SBOMs), and how to create them.

• 

  Creating a Medical Device Bootscreen for QNX

  QNX Medical Device Bootscreen tips for the popular micro-kernel OS designed for embedded systems and safety critical hardware.

There are no posts to show