Posts categorized as“Eastern Region”

Ryan Field

Tolerancing Simulation for Medical Device Optical Systems

Tolerancing is often an essential step in understanding the manufacturing/assembly requirements of an optical system designed for use in medical devices. The use of optical design software for tolerancing simulations is a valuable tool for identifying the specific manufacturing/alignment errors that can be allowed and their limits. Zemax OpticStudio® is a popular optical design software […]

Tammy Lee

Revolutionizing Medical Imaging Devices with Optical Imaging

Optical imaging tools can enhance the crucial role of biomedical imaging in accurately identifying diseases and monitoring their progression. Conventional medical imaging devices such as X-rays, computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, and positron emission tomography (PET) are commonly used in clinical settings (Figure 1). However, these imaging modalities are limited in their […]

Taimoor Khan

FDA Draft guidance: Marketing Submission PCCP Recommendations for AI/ML-Enabled Device Software Functions

The FDA recently (April, 2023) came out with a draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions. The document provides guidance for developing a Predetermined Change Control Plan (PCCP) for managing changes to the device software functions. The PCCP is a critical component of […]

Morna-Sunghyun

Do VR Design Tools Live Up To The Hype?

How VR design tools can improve product development VR is one of the hottest trending tools in Industrial Design. Whether on social media or at conferences, designers are talking about how they use VR in the design process. In fact, we wrote about how VR can change Medical Device Design – XR is about to […]

Deborah Pinchev

UK Medical Device Brexit Implications

On June 26, 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released the Government response to consultation on the future regulation of medical devices in the United Kingdom. This response will effectively guide the UK’s post-Brexit implementation plan for medical device regulation. The following are high-level key points that are sure to be […]

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