Tag

system
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....
Read More
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...
Read More
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...
Read More

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.