Alberto Turchi – Product Manager of Thema
Alberto Turchi, Product Manager of Thema, answered some questions about his work and role, also giving us valuable advices. Let's know [...]
14 02 2023
14 02 2023
07 02 2023
07 02 2023
European Authorised Representative: a more proactive and responsible role due to MDR
7 February 2023 Due to the changes introduced by the European regulation, it is necessary to have a good understanding of [...]
19 01 2023
19 01 2023
CHINA: updated safety standards for electroMedical Devices
As previously announced, technical safety tests are a key component of the registration process for Medical Devices in China. In this [...]
19 01 2023
19 01 2023
UK: MHRA increases registration fees for Medical Devices
During the consultation that ended on 23rd November, MHRA submitted proposals to change the mandatory registration fees for Medical Devices that [...]
19 01 2023
19 01 2023
EUROPE: MDR transition period extension proposed and latest MDCGs
On 6th January, the European Commission issued a proposal to extend the transitional period under Art. 120 for MDR until [...]
17 01 2023
17 01 2023
EMMA International Consulting Group, Inc. and Thema Announce Strategic Partnership.
Press Release available in PDF Ita PDF Eng PDF Esp Word Ita Word Eng Word Esp [...]
15 12 2022
15 12 2022
CANADA: Summary Reports required
Health Canada, the department of the Government of Canada responsible for national health policy, last 21st November issued a reminder for [...]
15 12 2022
15 12 2022
UK: new ways of reporting adverse events
Last 28th October, MHRA (Medicines and Healthcare products Regulatory Agency) announced that starting from Monday, 5th December 2022, adverse events involving [...]
15 12 2022
15 12 2022
EUROPE: MDR Annex XVI Common Specifications’ draft Act approved
Last 13th October, with much anticipated vote, the Medical Devices Committee of the European Commission voted on the draft Implementing Act [...]
01 12 2022
01 12 2022
MDR (EU) 2017/745: impact on communication and advertising of Medical Devices
Since MDR came into force, a lot has changed in the European context: in fact, MDR has sought to involve functions [...]
