Establish QMS compliance to ISO 13485 as a reagent manufacturer

Answer:

Even though your company does not manufacture the IVD set, the reagent forms part of the IVD set. Therefore, the above clauses of the medical device file, advisory notice, risk analysis, complaint handling still applies. Do take note that ISO 13485 is applicable to any company that deals with medical devices regardless of whether they are just providing design, installation, servicing and etc. For instance, in the case of complaint handling, if there is a reporting of contamination in the reagent, this is required to be documented with corrections and corrective actions taken. This would also escalate to field safety notice if the contamin ation leads to an erroneous result of the IVD kit leading to a batch recall.

For more information, please refer to the following material:

-Clause-by-clause explanation of ISO 13485:2016:
https://info.advisera.com/13485academy/free-download/clause-by-clause-explanation-of-iso-13485

-How to use ISO 14971 to manage risks for medical devices
https://advisera.com/13485academy/blog/2017/09/21/how-to-use-iso-14971-to-manage-risks-for-medical-devices/