The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.continue reading »
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The value of competence and training in developing and maintaining a quality workforce is well understood. Yet, many organizations struggle with providing, documenting, and evaluating the effectiveness of their training efforts. This is often revealed in audit findings that point to deficiencies such as a lack of establishing procedures for training and identifying training needs, a lack of training evaluation, and a lack of evidence that personnel have sufficient training and can adequately perform job-related duties. As the audit findings imply, it’s not enough to verify the existence of training records. Organizations must now determine the necessary competence of personnel and assess the effectiveness of any training being provided to maintain that competency.
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Although initially they may be deemed to be more expensive and complicated, MDSAP audits will provide a more efficient way of ensuring compliance with QMS and at the same time, reduce the audit/inspection burden on both medical device companies and regulatory authorities. In this blog I will provide a basic overview of the program and offer suggestions to prepare manufacturers for MDSAP.continue reading »
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A cable support bracket with 2 threaded inserts and a weld, created in Solidworks 2016
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From a regulatory standpoint the differences between IEC 62366:2007 and IEC 62366 -1:2015 are minimal, with all the same boxes needing to be ticked. However, it is clear from reading the documentation that the whole process has been streamlined, using more familiar language and on the whole a more usable standard. Probably a good thing from a usability document, I guess! The biggest unknown was Fig. 5.10 User Interface of Unknown Provenance (UOUP).continue reading »
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Author tends to cyro-preserved mammalian cell lines in our BSL2 facilities at the University of Victoria.
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Last week my blog discussed a major drawback to multi-layer ceramic chip capacitors (MLCCs) that is poorly understood by even experienced engineers: DC bias effects on capacitance. So, now that we know that DC bias effects can be significant: what can we do about it?continue reading »
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Multi-layer ceramic chip capacitors (MLCCs) are the most common capacitor found in modern electronics. MLCCs have many attractive features: low ESR, good capacitance-to-volume ratio, relatively low leakage, non-polarity, and low cost. It’s no wonder that when choosing a capacitor, an electrical engineer will usually specify a ceramic first before any other type.continue reading »
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Computer games and medical device design both begin conceptually in a somewhat similar space – a point where reality and science fiction meet. From there the directions they take are infinitely different but the processes are virtually identical. I recently spoke on a panel at our local Global Game Jam (the world’s largest game jam event) about User Experience and Human Factors. I went excited to tell all these budding game developers about UX from a different perspective. I didn’t expect to learn there are so many similarities between the two.continue reading »
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June is the month of many university graduations. In the spirit of continuous education, we asked our writers to identify medical device project tips they’ve learned from on the job experience. Here are 11 solid tips that will help you commercialize your medical device.