Tag

design
07
Mar

Describing Software Design

March 7, 2025
Refreshing to see such a clearly articulated discussion of #software #design. A good reminder that #softwarequality is “designed-in,” not “tested-in.” Kudos @flightaware https://t.co/CmxySpg6VH — @softwarecpr (@softwarecpr) March 7, 2025 Can #medicaldevice companies rediscover the inherent #quality benefit one gains from well thought out, peer-reviewed software design? This is just one of the topics we will...
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04
Apr

Challenges and benefits of the microservice architectural style

April 4, 2021
An excellent overview of the challenges and benefits of the Microservices architectural style of software application development.  While many of the factors discussed by the author (Dr. André Fachat, published January 30, 2019), these same factors can affect the safety and efficacy of a medical devices using this style.  The article consists of two parts:...
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SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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