Two new medical device commercialization blogs and authors joined our 2019 “most read” list. Regulatory and electrical engineering articles tied for most popular topic (4 each), followed by biotech and supply chain. Many thanks to our employee authors past and present for their contributions to medical device excellence.
- How ISO 13485:2016 section 7 changes impact your QMS is part two of Michael May’s series on 13485:2016 section 7. The majority of changes in going from ISO 13485:2003 to ISO 13485:2016 relate to risk and documentation and the training required to competently implement them all. There is no question that ISO 13485:2016 section 7 changes will impact your Quality Management System (QMS). The two major themes in changes to the ISO 13485 standard are taking a risk based approach and documenting everything. They are also two of the core differences in section 7, “Product Realization”.
- 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. Nigel Syrotuck explains how 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 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.
- 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.
- An electrical engineer’s overview of IEC 60601-1 Terminology & Definitions through Annexes Part 2 of Bjarne Hansen’s Electrical Engineer’s overview of one of the more important standards for medical devices: IEC 60601-1. IEC 60601-1 is not just an electrical safety standard. At StarFish we use several checklists and templates to ensure we address all of its comprehensive requirements.
- Supplier Quality Agreement or Supply Agreement? Laura Meyer shares her supply chain expertise in this perennial favorite. In the early stages of medical device development, it is usually sufficient to secure pre- production quantities through a simplified procurement cycle. A specification, a quote, a purchase order and a certificate of conformance —what other paperwork is needed? Why clutter up a simple, well defined process with other documents and paperwork?
- 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 Christian Proch-McMechan covers in his blog are in addition to the standard risk management, requirements, specification, and architecture documents.
- Determining the best method to detect E. coli Various methods exist to detect E. coli, amongst them are PCR, gold nanoparticles for a visual colour change confirmation and fluorescent labelled enzymes. Azra Rajwani joins our list of most read authors with a blog that outlines the detection methods mentioned above, and helps narrow down which detection method is best suited for a specific application.
- Unit testing in embedded systems: 3 myths and an automated tip There are a range of modern techniques that can be used to facilitate better reliability of embedded firmware. One thing that Peter Kazakoff is a big fan of is unit testing. Embedded engineers opposed to unit testing will raise a few common objections. Peter decided to write his blog debunking three common myths and share his experience using an automated unit testing tool after seeing firsthand how unit testing can improve medical device firmware quality.
Astero StarFish is the attributed author of StarFish Medical team blogs. We value teamwork and collaborate on all of our medical device development projects.