Keeping OrthoPureXT on the radar21 Apr 2020 16:15
The recent Hardman report on TRX submitted the following with regards OrthopureXT.
"CE marking of OrthoPure XT
All the audits by the external examiners appointed by the notified body have been completed. Feedback from these audits to the notified body can take up to eight weeks. The main issue, as seen with many companies, is that the notified bodies
have a log-jam following the introduction of the new Medical Device Directive. We believe TRX is close to approval, which is expected during 1H’20".
I know the finance issue will take precedence but I wonder if world events have delayed this accreditation. Still, it is something else to look forward to and shouldn't be underestimated.
Stay safe everyone.