(Total Views: 345)
Posted On: 10/25/2019 9:23:47 AM
Post# of 8404
I agree Disco, Uncertainty about a company's leadership is treated negatively by investors. I do believe that when the leadership announcement is made BIEL will rebound.
IMO we need the CE approval to get a large jump in revenue. Thankfully, per the last Update, all of the Inspections/Certifications are done and it should be finalized soon, could be a done deal already
CE Mark Renewal Status Update
We are pleased to announce that BioElectronics has passed the on-site audit for its ISO 13485:2016/MDD re-certification. Our regulatory affairs manager is working with the auditing body (NEMKO/Presafe) to supply post-audit documentation. We anticipate that the ISO 13485:2016 certificate will be issued shortly, and be valid until October 2022.
On Friday, October 11 we submitted the information requested by the notified body (NEMKO/Presafe), to resolve the remaining items on the checklist required for the updated CE technical file certification. We are awaiting review by the notified body's assessor in Norway, following which the technical file and ISO 13485:2016 certification information will be submitted for re-certification of the CE mark.
IMO we need the CE approval to get a large jump in revenue. Thankfully, per the last Update, all of the Inspections/Certifications are done and it should be finalized soon, could be a done deal already
CE Mark Renewal Status Update
We are pleased to announce that BioElectronics has passed the on-site audit for its ISO 13485:2016/MDD re-certification. Our regulatory affairs manager is working with the auditing body (NEMKO/Presafe) to supply post-audit documentation. We anticipate that the ISO 13485:2016 certificate will be issued shortly, and be valid until October 2022.
On Friday, October 11 we submitted the information requested by the notified body (NEMKO/Presafe), to resolve the remaining items on the checklist required for the updated CE technical file certification. We are awaiting review by the notified body's assessor in Norway, following which the technical file and ISO 13485:2016 certification information will be submitted for re-certification of the CE mark.
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