T
Taimoore
Hello Folks,
I am new to these standards and hope that you can patiently answer some of my silly questions.
We are very small company that develops Radiology Imaging PACS systems. We are categorized as PACS device (892.2050 LLZ) under title 21 CFR part 820. The DICOM PACS and DICOM VIEWER are catergorized as CLASS II with Moderate Level of Concern device.
This is a completely software based Class II medical device.
We are interested in getting USA-FDA and Europe CE approved so that the device can be recognized in both continents.
My question is what would be the best approach to perform the complete SDLC process that can adhere to both the FDA and CE standards.
I looked into the ISO/EN IEC 62304:2006 as well the documentations related to FDA 510(k) submission standards. But what would be best route that would incorporate and be acceptable/compatible to both standards?
Are there any Test plan templates that I can use for Test Validation and Verification?
What are the steps involved in the IE 62304 and FDA 510(K) that are similar and what steps are not?
My goal is to certify with both standards and find processes that compliment both FDA 510(k) and CE (IEC 62304:2006).
Please need your guidance and help. Are there any templates that I can use for each step of the process from Research & Analysis to Deisgn and testing etc?
Thank you for hearing me out.
Best regards
Tim
I am new to these standards and hope that you can patiently answer some of my silly questions.
We are very small company that develops Radiology Imaging PACS systems. We are categorized as PACS device (892.2050 LLZ) under title 21 CFR part 820. The DICOM PACS and DICOM VIEWER are catergorized as CLASS II with Moderate Level of Concern device.
This is a completely software based Class II medical device.
We are interested in getting USA-FDA and Europe CE approved so that the device can be recognized in both continents.
My question is what would be the best approach to perform the complete SDLC process that can adhere to both the FDA and CE standards.
I looked into the ISO/EN IEC 62304:2006 as well the documentations related to FDA 510(k) submission standards. But what would be best route that would incorporate and be acceptable/compatible to both standards?
Are there any Test plan templates that I can use for Test Validation and Verification?
What are the steps involved in the IE 62304 and FDA 510(K) that are similar and what steps are not?
My goal is to certify with both standards and find processes that compliment both FDA 510(k) and CE (IEC 62304:2006).
Please need your guidance and help. Are there any templates that I can use for each step of the process from Research & Analysis to Deisgn and testing etc?
Thank you for hearing me out.
Best regards
Tim