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Greetings, Fellow Covers!
I am having a dispute with my NB regarding our scope statement for ISO 13485:2003 (CMDCAS). They insist it must slavishly follow the template that Health Canada recommends in GD 207 for non-IVD devices; specifically that it must include a 'for the area of' statement.
Our current scope statement, which we hammered out in conjunction with the same NB two years ago, is "Design and development, Manufacture, installation, and service of medical device imaging and communication software systems." Essentially, our product offers Picture Archiving and Communication System (PACS)-type functionality.
Somehow, after two years of being acceptable, and after a surveillance (not renewal) audit, [FONT="][/FONT]the NB claims that we need to add 'for the area of __' to the scope. Our software is not limited to a certain clinical scope - it can be used to display and communicate multiple kinds of medical images (e.g., RT, CT, PET scans, etc.) to facilitate whatever you would need to display/communicate them for. We do have a focus area in radiation oncology (which our NB apparently does not understand is distinct from radiology, which is the 'area of' their 'experts' want to add), but the functionality is not limited only to that.
In GD 207, Health Canada does not require adherence to the exact formula provided in their templates (which are, themselves, not exhaustive in terms of possible terms to include). They only 'strongly recommend' the format. Furthermore, there are illustrative examples - and those examples do not include all elements from the recommended templates. There is even an example (B2) with a hypothetical product that includes imaging-oriented functionality that does not have any 'for the area of' language at all. Health Canada plainly recognizes that a single template is not suitable for all use cases.
I've pointed this out, and asked for an explanation for why the current scope statement is suddenly no longer acceptable. Their response has amounted to "The template is mandatory, and we are experts and this is our opinion."
I do not want to limit my scope statement to a single 'area of' when that does not accurately represent the actual scope of the product's use. And I certainly do not accept their claim that such language is mandatory when the guidance document clearly states the template is only recommended, and its illustrative examples do not follow it slavishly. Help?
(P.S. - This entire issue was only communicated to me when I refused to pay the invoice for the recent surveillance audit, which took place over three weeks ago, because I had yet to receive the audit report....)
I am having a dispute with my NB regarding our scope statement for ISO 13485:2003 (CMDCAS). They insist it must slavishly follow the template that Health Canada recommends in GD 207 for non-IVD devices; specifically that it must include a 'for the area of' statement.
Our current scope statement, which we hammered out in conjunction with the same NB two years ago, is "Design and development, Manufacture, installation, and service of medical device imaging and communication software systems." Essentially, our product offers Picture Archiving and Communication System (PACS)-type functionality.
Somehow, after two years of being acceptable, and after a surveillance (not renewal) audit, [FONT="][/FONT]the NB claims that we need to add 'for the area of __' to the scope. Our software is not limited to a certain clinical scope - it can be used to display and communicate multiple kinds of medical images (e.g., RT, CT, PET scans, etc.) to facilitate whatever you would need to display/communicate them for. We do have a focus area in radiation oncology (which our NB apparently does not understand is distinct from radiology, which is the 'area of' their 'experts' want to add), but the functionality is not limited only to that.
In GD 207, Health Canada does not require adherence to the exact formula provided in their templates (which are, themselves, not exhaustive in terms of possible terms to include). They only 'strongly recommend' the format. Furthermore, there are illustrative examples - and those examples do not include all elements from the recommended templates. There is even an example (B2) with a hypothetical product that includes imaging-oriented functionality that does not have any 'for the area of' language at all. Health Canada plainly recognizes that a single template is not suitable for all use cases.
I've pointed this out, and asked for an explanation for why the current scope statement is suddenly no longer acceptable. Their response has amounted to "The template is mandatory, and we are experts and this is our opinion."
I do not want to limit my scope statement to a single 'area of' when that does not accurately represent the actual scope of the product's use. And I certainly do not accept their claim that such language is mandatory when the guidance document clearly states the template is only recommended, and its illustrative examples do not follow it slavishly. Help?
(P.S. - This entire issue was only communicated to me when I refused to pay the invoice for the recent surveillance audit, which took place over three weeks ago, because I had yet to receive the audit report....)