Overview of what we do for context:
We don't make medical devices or software and are a small company. We do contract fermentations for enzymes/biologics (and will eventually have our own products) that may be used by companies that make diagnostic kits and/or vaccines - They would be components for such things... BUT would be technical grade which our customers would then polish and either use themselves or sell to others to incorporate into such products. So it's more like a crude chemical the the customer refines before using in their Diagnostic kit or vaccine production rather than a direct device component component,
We are recently ISO-9001 certified but with a design exclusion. Since then have both decided to become ISO-13485, Keep 9001 AS WELL as develop our own product that fits the one category I mentioned above.
So my question, since our potential product is not a medical device or something that is sued as is in a device, would it be covered under the Deign causes of 13485?
For sure we have to change our ISO9001 registration to include design, but would it's design fall under 13485?
BTW In General I know ISO9001 is less proscriptive than 13485, Does that apply to design as well for 13485 Vs 9001?
Is this a stupid question? (meaning no significant difference?)
Thanks,
-Karen
We don't make medical devices or software and are a small company. We do contract fermentations for enzymes/biologics (and will eventually have our own products) that may be used by companies that make diagnostic kits and/or vaccines - They would be components for such things... BUT would be technical grade which our customers would then polish and either use themselves or sell to others to incorporate into such products. So it's more like a crude chemical the the customer refines before using in their Diagnostic kit or vaccine production rather than a direct device component component,
We are recently ISO-9001 certified but with a design exclusion. Since then have both decided to become ISO-13485, Keep 9001 AS WELL as develop our own product that fits the one category I mentioned above.
So my question, since our potential product is not a medical device or something that is sued as is in a device, would it be covered under the Deign causes of 13485?
For sure we have to change our ISO9001 registration to include design, but would it's design fall under 13485?
BTW In General I know ISO9001 is less proscriptive than 13485, Does that apply to design as well for 13485 Vs 9001?
Is this a stupid question? (meaning no significant difference?)
Thanks,
-Karen