Bioelectronics Corp (BIEL)

[JustGoDeep]

CE Mark Renewal Status Update (From 08/02/2019 Update)

We are pleased to announce that the ISO 13485:2016 certification has been completed at our overseas manufacturer’s facility. We are working with the notified body (NEMKO/Presafe) to resolve the last few remaining items on the checklist required for the updated technical file certification.
As part of the CE renewal efforts, we are also working on our on-site ISO audit and MDSAP certification requirements, which will obtain and extend ISO 13485:2016 certification to five partner countries (Brazil, Canada, USA, Japan & Australia.)
The ISO/MDSAP certification, along with the technical file, comprise the two parts required to meet the updated CE mark requirements.