The top 10 StarFish Medical blogs of 2017 feature a heady mix of regulatory, engineering, and practical information and advice. Seven of the blogs are perennial favorites with high ranking on Google and other search engines. The remaining three are from new writers and hint of new evergreen standards in the works. New or tried and true, these 10 StarFIsh Medical blogs are worth reading and sharing.
- 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.
- 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.
- 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.
- 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?
- 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.
- 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.
- How to identify a Conformité Européenne mark vs a China Export mark The Conformité Européenne (CE) mark is a common sight on products in North America, and Europe. However the China Export mark and CE mark are easily confused, which is understandable because they look almost identical. This similarity is something which has been acknowledged by the EU parliament.
- 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.
- Why an electrical isolation diagram improves your medical device design As tempting as it is to start ordering parts and tinkering for your medical device, there are a few preliminary documents you can create to help you choose the right parts. Eventually you’ll need a design that must pass the requirements of IEC 60601-1. Drafting documents now will prompt you to ask the right questions early and hopefully solve any core technology safety related hurdles early. The documents I discuss below are in addition to the standard risk management, requirements, specification, and architecture documents.
- Apply for a job at StarFish Medical: our interview process We engage our candidates in a thorough interview process which can include multiple interviews with a variety of our team. These interviews can be overwhelming to some candidates and we recognize that. But it’s proven to be a great way to understand who will find success at StarFish Medical. As well, it gives the potential employees a much broader understanding of who StarFish Medical is, so they can determine if we will be a good fit for them. We strongly believe that the process of interviewing with a company is a two way street.
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Astero StarFish is the attributed author of StarFish Medical team blogs. We value teamwork and collaborate on all of our medical device development projects.