BBS-Bioactive Bone Substitutes – The company provides an update on the CE marking process related to the approval of the quality system – consultation with the Finnish Medicines Agency to begin on 21 ...

BBS-Bioactive Bone Substitutes – Inside information: The final report of the second audit received from the Notified Body, CE marking process may continue and CE marking approval continues to be ...

“The EU applies the CE Marking process primarily to ensure safety, as well as a reinforced manufacturer obligation with respect to device claims. The FDA does this too, but has the additional ...

In July 2020 BBS received the draft agreement concerning the implementation of CE marking process of ARTEBONE ® from Notified Body (BSI). The Company began preparations to submit CE marking ...

BBS Bioactive Bone Substitutes Oyj ‘s Notified body BSI has become to the conclusion that the provided clinical data is insufficient as required by the new MDR and as a result they will proceed ...

Dublin, Nov. 14, 2023 (GLOBE NEWSWIRE) -- The "Medical Device School - From Concept to CE Marking Training Course" has been added to ResearchAndMarkets.com's offering. This course is meticulously ...

The CE marking process with certification body, DEKRA, is progressing according to plan with all technical modules already completed. The last module, related to the clinical data, will be completed ...

BBS-Bioactive Bone Substitutes Plc, Company announcement, Insider information, 13 September 2023 at 4:45 p.m. BBS-Bioactive Bone Substitutes Plc – Insider information: Plan to complete minor open ...

LANCASTER, Pa., Feb. 25, 2025 /PRNewswire/ -- Advanced Cooling Technologies, Inc. (ACT), a leading provider of thermal management solutions, announces a significant milestone in its global expansion.