Our annual summary of most read medical device blogs is always popular. This year it may also feel familiar. The top four blogs were previously on last year’s list.
What makes them stand the test of time? Check them out and let us know. Our bloggers love hearing from readers.
1 How to Handle Medical Device Risk Management and the change from ALARP to AFAP As part of design and development at StarFish, we undertake Risk Engagements with key Stakeholders, and create a Medical Device Risk Management file, which demonstrates that risks are controlled. This blog provides details on the Directive and Standard, examines implications for the recent changes, and explains how we handle the situation. Vincent Crabtree, PhD wrote this while a Regulatory Advisor and Project Manager at StarFish Medical.
2 Inexpensive prescreening strategies for medical device EMC compliance should have its own fan club. Bjarne Hansen is an Electrical Engineer at StarFish Medical. Bjarne has been contributing to novel medical products at StarFish for 12 years, and particularly enjoys designing embedded systems. This article includes steps one can take during product development to ease the task of medical device EMC compliance. As a bonus, Bjarne has included lots of images to help illustrate his points.
3 Pros and cons of two popular Ultrasound signal processing techniques There are a number of methods of demodulation in ultrasound although two ultrasound signal processing techniques are used predominately nowadays. Kenneth MacCallum, PEng, Principal Engineering Physicist at Starfish Medical offers the pros and cons of both methods and concurs they will both likely be used for the foreseeable future.
4 Toyota, SOUP, and Medical Device Development Kenneth MacCallum’s second top 10 blog has been on the charts since 2013. Perhaps because it’s pretty much impossible to write software without some third party code creeping in. IEC62304:2006 calls this “Software of Unknown Provenance” or SOUP, referring to software with unknown safety-related characteristics, or developed under an unknown methodology. Operating Systems, code libraries supporting the CPU, or even artifacts created by the compiler can all leave chunks of code in medical device applications that don’t write and don’t know for certain are safe. Kenneth explains all.
5 Will new FDA final rule on symbols for device labels make devices cheaper? In June, FDA finally dropped their requirement for symbols for device labels to be explained with adjacent text and now allows the use of standalone symbols on medical device and In Vitro Diagnostic (IVD) labels as long as certain requirements are met. Whether Industry sees a reduction in medical device manufacturing cost as a result of this new rule is yet to be seen.
6 RoHS 2 vs RoHS 3 impact on medical devices RoHS 3 – The Trilogy is Complete. The Restriction of Hazardous Substances (RoHS), has had a substantial and permanent effect on the materials that go into many of the electronic products we make. Knowing what to look for and finding good vendors with appropriate quality programs will lead to a smoother product development program and faster time to market.
7 Why is my stainless steel rusting? While the conditions required for stainless steel rusting are more likely to occur in medical lab equipment where stainless and salt solutions come together, it can happen in any device, including implants.
8 How ISO 13485:2016 changes will impact your QMS (sections 4-6) With the March 1, 2016 release of ISO 13485:2016, medical device developers and manufacturers have been given a three year grace period to implement changes from the previous 2003 version. During those three years both the 2016 and 2003 versions will be valid to operate under; however after the three year grace period, compliance with the 2016 version will be mandatory. So what are the major changes and how are organizations to address them?
9 5 Similarities and Differences between Medical Device 510(k) and CE Marking Pt. 1 The regulatory strategy of North American medical device companies is usually well defined – Section 510(k) of the Food, Drug and Cosmetic Act from the Food and Drug Administration (FDA) is the preferred route. However, there are instances where launching in Europe first with a European Commission (CE) mark can be beneficial (such as with a novel device), or it can simply be a matter of time before one wishes to expand and launch in Europe. This blog covers Terminology, Device Risk Classification, and Process.
10 5 Similarities and Differences between Medical Device 510(k) and CE Marking Pt. 2 While 510(k) is the preferred regulatory strategy of many North American medical device companies, launching in Europe first with a CE mark can be beneficial. This blog concludes highlights of 510(k) and CE Marking similarities and differences. It explores the Quality Management System (QMS) and Documentation aspects, and conclude with a Prologue.