18 Jan Decrease Time-to-Market by Developing Medical Device Software “In the Spirit” of IEC-62304
Getting any new medical device to market is a race against time, and it’s so tempting to jump in and start coding from the get-go. But hold your horses – you’ll save time in the long run, and potentially improve the valuation for your company,...
14 Oct Key#™ and Bluetooth Low Energy (BLE)
Since its release, Key#™, Key Tech’s configurable software tool, has provided customers a variety of advantages when developing device prototypes and running assays. This proprietary tool benefits our clients by accelerating prototype development and testing. Although we’ve covered several benefits and applications of the Key#™...
14 Jul Re-Architecting Software Following the Spirit of 62304
Every medical device manufacturer (MDM) is intent on speeding up development, keeping costs down, and getting to market fast--all while delivering a safe, accurate, and reliable product. For some projects, a device falls outside the FDA’s regulatory jurisdiction and thus will not require step-by-step compliance with...
20 Jan Leveraging Key#™ To Speed Up Your Assay Development
To follow up on our original article on Key Sharp (Key#™), we want to examine how Key#™ can be used by your assay team to speed up the chemistry development for an IVD platform. Key#™ is a PC-based software framework Key Tech has developed for the...
16 Apr Software of Unknown Provenance
To follow up on Lei Zong's post last week about threat assessments, a specific area of concern that is overlooked is related to vulnerabilities of Software of Unknown Provenance (SOUP) items. The FDA has been working to change that by requiring a more systematic approach...
07 Apr Navigating Cybersecurity Threat Assessments
During this challenging time, cybersecurity for medical instruments should be on the forefront of every device designer’s mind, particularly those life-saving devices such as ventilators. It is imperative to incorporate cybersecurity strategies into each step of the software development process, from architecture threat assessment to penetration...