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Ravimiamet · 11. märts 2025
- Viit
- MSO-13/1271-1
- Registreeritud
- 11. märts 2025
- Dokumendi liik
- Sissetulev kiri
- Adressaat
- Syneos Health
- Saabumis/saatmisviis
- e-post
- Funktsioon
- MSO Meditsiiniseadmed
- Sari
- MSO-13 Meditsiiniseadmete kliiniliste uuringute ja toimivusuuringute dokumendid (taotlused, load, muud teavitused ja kirjavahetus)
- Toimik
- MSO-13/2025
- Vastutaja
- Merili Saar-Abroi (RA, Meditsiiniseadmete osakond)
Sisu (failidest)
Saatja: Martello, Daiana <[email protected]>
Saaja: RA MSO, SPVG Regulatory Intelligence
Teema: Clinical investigations with Medical Devices - Safety reporting email address
Dear Sir/Madam,
I am a Safety Specialist at Syneos Health (Clinical Research Organization), a company responsible for Safety reporting on behalf of Sponsors in the frame of Clinical Investigations with Medical Devices and In Vitro Diagnostics (IVDs).
In the context of the announcement published on 1 January 2025 on the Ravimiamet website (link <https://ravimiamet.ee/uudised/2025-aastal-tuuakse-meditsiiniseadmete-valdkonna-padevus-ule-ravimiametisse-0> ), we would like to confirm that the email address [email protected] <mailto:[email protected]> can be used to submit safety reports arising from Clinical Investigations with Medical Devices.
Thanks in advance for your support.
Kind regards,
Daiana
Daiana Martello
Sr Safety & PV Ops Specialist
Syneos Health
syneoshealth.com <http://www.syneoshealth.com/>
<https://www.syneoshealth.com/>
Upcoming absence: 17-Apr-2025, 18-Apr-2025, 1-May-2025
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