S
Hello,
I'm a biomedical software engineer (not a quality guy), and my company is starting to make their first medical software product. I've worked under the quality management systems in the past, but this company does not have one and I have no idea how to start it.
The company is ISO 9001 certified, and we have another project which is appraised at CMMI ML3 (the company, however, is not CMMI).
I have found a white paper from CMU mapping CMMI to IEC 62304 and a published book section called "Mapping Medical Device Standards Against the CMMI for Configuration Management" , but the latter I haven't read yet (SpringerLink).
(Wishes he could post links).
Are there any other good resources for this? I don't want the company to have ISO 9001, ISO 13485, CMMI, cGMP, ISO 14971, and IEC 62304 documents separately... it seems quite silly.
Is there a way to show that what we have with our ISO 9001 and CMMI ML3 meets X, Y, Z requirements of ISO 13485 and 21 CFR 820, and then supply the missing documentation under ISO 9001 and CMMI manner? (I know 21 CFR 820 requires some CMMI ML5 stuff when it comes to safety) the CMMI stuff will need to be re-written for the new project, but I'd love to be able to start with something.
Any help is greatly appreciated, thanks!
-Stephen Furlani
Biomedical Software Engineer
I'm a biomedical software engineer (not a quality guy), and my company is starting to make their first medical software product. I've worked under the quality management systems in the past, but this company does not have one and I have no idea how to start it.
The company is ISO 9001 certified, and we have another project which is appraised at CMMI ML3 (the company, however, is not CMMI).
I have found a white paper from CMU mapping CMMI to IEC 62304 and a published book section called "Mapping Medical Device Standards Against the CMMI for Configuration Management" , but the latter I haven't read yet (SpringerLink).
(Wishes he could post links).
Are there any other good resources for this? I don't want the company to have ISO 9001, ISO 13485, CMMI, cGMP, ISO 14971, and IEC 62304 documents separately... it seems quite silly.
Is there a way to show that what we have with our ISO 9001 and CMMI ML3 meets X, Y, Z requirements of ISO 13485 and 21 CFR 820, and then supply the missing documentation under ISO 9001 and CMMI manner? (I know 21 CFR 820 requires some CMMI ML5 stuff when it comes to safety) the CMMI stuff will need to be re-written for the new project, but I'd love to be able to start with something.
Any help is greatly appreciated, thanks!
-Stephen Furlani
Biomedical Software Engineer
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