Tag

system
22
Jun

Design and Development Planning

June 22, 2023
The US regulations for design controls have requirements for design and development planning.  In fact, a design and development plan is an indication that a manufacturer has “exited” research phase activities and entered the development phase, and thus, design controls should be in place.  The regulation, 21 CFR 820.30(b), specifically states: Design and development planning....
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28
Feb

MDCG SARS-CoV-2 Performance Evaluation

February 28, 2022
In February 2022, the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745, released revision 1 of MDCG 2021-21, Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices.  You can view the copy at this link: MDCG 2021-21 Rev.1 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical...
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22
Jan

Safety Modeling Articles related to JPL mission

January 22, 2008
Dr. Nancy Leveson of MIT indicated that there are some new papers involving a demonstration of STAMP (and STPA) being used for safety-driven design of a new JPL mission to Europa including a very complete example. A JPL modeling language was incorporated (JPL was funding the work), but had little to do with the final...
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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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