In order to assure the company QMS and product Technical Documentation are in compliance with applicable regulations, it is valuable to execute gap analyses at certain critical time points or to find any gaps that need to be closed. This is of vital importance, if your company is planning for an authority audit, and would like to get your system and/or product regulatory compliance controlled before you feel ready for the real audit or when a standard or regulation has been updated, and you need to assure you are in compliance.
By asking SDS to run a gap analysis, you will get feedback on any missing parts of your QMS and/or technical documentation, as well as a recommendation on how to mitigate these gaps. If your organisation is also in need of getting support to mitigate the gaps, SDS MedteQ will of course have the knowledge to support you in this endeavour. This may save you plenty of time and issues, since this gives you the opportunity to fill in those gaps by yourself prior to authorities identifying them.
SDS MedteQ are running gap-analyses from different regulatory and standards perspectives such as MDR 2017/745, 21 CFR 820, ISO 13485, ISO14971, ISO 62304 and other standards depending on the needs of the company.
