VDI 5702
The VDI 5702 is a series of guidelines of the Department of Medical Technology of the Association of German Engineers . The VDI guidelines contained in it are written in German and English.
The series of guidelines VDI 5702 has the main title "Medical Device Software - Medical SPICE" with the respective individual topics in separate guidelines:
- Sheet 1 "Process assessment model"
- Sheet 2 "Assessor qualification (in preparation)"
- Sheet 3 “Best Practices; Process group software development "(in preparation)
Content
The standards IEC 62304, IEC 62366, ISO 13485 , ISO 14971 and possibly IEC 60601 (for hardware components) specific to medical software development overlap in some topics. On the one hand, the VDI guideline 5702 summarizes the contents in a clear manner for various process groups:
Corresponding to the SPICE process model, the guideline also enables an assessment of the quality of the associated processes and information.
The guidelines are drawn up by experts in voluntary joint work in a transparent process with public participation.
Web links
Individual evidence
- ↑ VDI 5702 sheet 1 - Medical device software - Medical SPICE process assessment model . ( vdi.de [PDF; accessed on February 5, 2020]).
- ↑ VDI 5702 sheet 2 - Medical device software; Medical SPICE; Assessor qualification . ( vdi.de [accessed on February 5, 2020]).
- ↑ VDI 5702 sheet 3 - Medical device software; Best practices; Software development process group . ( vdi.de [accessed on February 5, 2020]).
- ^ VDI, Nicholas Engel: Medical SPICE: Software development processes in medical technology. Retrieved February 5, 2020 .
- ↑ Medical SPICE: Software development processes in medical technology - New VDI 5702 Part 1 is "Guideline of the Month" May . In: beam-Verlag (ed.): Meditronic-journal . No. 3/2016 .