Jasminka Roth

Proven long-term track record as a leader for strategic quality management. I enjoy creative and innovative approaches. Current focus: Strategic Intelligence

[Jasminka Roth @jasminka_roth]

Congratulations to a great initiative with our German speaking neighbors!

[The Tao of Excellence @taoexcellence]

News in the German speaking #Medtech industry! 🇩🇪🇨🇭🇦🇹
AUSTROMED, @BVMed , and Swiss Medtech, representing #Austria, #Germany, and #Switzerland respectively, have signed a Collaboration Agreement at a joint board meeting in Berlin on December 1, 2023. 1/5
https://t.co/CpSECbaH5b

[The Tao of Excellence @taoexcellence]

Are you feeling stuck and uncertain about the complex regulations?
Our step-by-step e-learning course is your guide to understanding the regulatory requirements, covering all facets as defined in the #MDR and #MedDO / #IvDO.
Say goodbye to confusion and hello to expertise!

[The Tao of Excellence @taoexcellence]

📣 News for the #MedicalDevicesIndustry in #Switzerland! 🇨🇭
Update on the #MedDO and #IvDO!
Switzerland has implemented significant regulatory changes to harmonize its Ordinances with the European Union. 1/6
https://t.co/ivAX1E9Mip

[Jasminka Roth @jasminka_roth]

@FlorianDreaming Die Apple Watch ist ein Medizinprodukt und ist als solches ce markiert. Hier ein Link zur entsprechenden Studie:

https://t.co/3xEIt27Z6W

[MedTech Europe @medtecheurope]

📢The @IHIEurope calls 4 & 5 have been launched!

Curious about the process of submitting a proposal? MedTech Europe has a wealth of resources available, including an informational video, and proposal templates & guidelines.

Star with this handy guide: https://t.co/kbuAbE6xOu

[Jasminka Roth @jasminka_roth]

#NewProfilePic

[The Tao of Excellence @taoexcellence]

The #ICH has released a reflection paper on "International Harmonisation of #RWE Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using #RWD, with a Focus on Effectiveness of Medicines." https://t.co/yE9bSpKTAG

[Jasminka Roth @jasminka_roth]

#NewProfilePic

[The Tao of Excellence @taoexcellence]

Info for manufacturers/importers of #medicaldevices in #Switzerland! Expired #MDD certificates have a transition provision under EU regulation 2023/607. @Swissmedic supports it. ⚠️Attention! Swiss requirements still apply, including CH-REP. Contact us for compliance support.

[The Tao of Excellence @taoexcellence]

Informationen für Hersteller/Importeure von #Medizinprodukten in der #Schweiz! Abgelaufene #MDD-Zertifikate haben eine Übergangsregelung gemäß EU-Verordnung 2023/607. @Swissmedic_ unterstützt dies. ⚠️Achtung! Schweizer Anforderungen gelten weiterhin, einschließlich CH-REP.

[The Tao of Excellence @taoexcellence]

For #medicaldevice manufacturer in #Europe and #Switzerland! 🇨🇭
Customers have reached out to us to assess, review and comment on how to communicate the extension of their #MDD and #IVDD certificates under the regulation (EU) 2023/607 amending the #MDR and #IVDR. 1/5

[The Tao of Excellence @taoexcellence]

Update on the #MDSAP audit approach document❗️
What are the changes in this version 008?
https://t.co/xHI2nhuTqr 1/7
#medicaldevice #MDSAP #qualitymanagement #regulatorycompliance #regulatoryaffairs #medtech #FDA #compliance #medicaldevices

[The Tao of Excellence @taoexcellence]

Exiting news! 📣🇨🇭
@Swissmedic_ published their official position regarding the Regulation 2023/607 on transition extensions under #MDR and #IVDR!
https://t.co/GCkTzAuXxp 1/6
#medicaldevices #EU #EUMDR #EUIVDR #Switzerland #Swissmedic #certificates #marketaccess #regulations

[The Tao of Excellence @taoexcellence]

Check out our new regulatory document matrix for #medicaldevices!
https://t.co/veshxVG8eo
👉Do you know all the documents required?
👉Do you understand how they differ for #Switzerland compared to #EU?
👉Do you recognize all abbreviations that the CH-REP is asking for? 1/5

[Ifff @[email protected] @Iff85678573]

https://t.co/ZxlKBooS4O

[Jasminka Roth @jasminka_roth]

Significant decision for medical devices in Switzerland:

[The Tao of Excellence @taoexcellence]

#Market access for #FDA approved #medicaldevices in #Switzerland!
The motion from Councillor of States Damian Müller "For more room for maneuver in the procurement of medical devices to supply of the Swiss population" was accepted. 1/4
https://t.co/pKnHpUr1pi

[Jasminka Roth @jasminka_roth]

Yes!

[Jasminka Roth @jasminka_roth]

This is amazing!

[nature @Nature]

Wasp-inspired drones can 3D print a building https://t.co/lfOFxXQwH5

[The Tao of Excellence @taoexcellence]

🚨 Alert for all economic operators using #EUDAMED!
The #EUDAMED team has released a warning about phishing via EUDAMED: 1/5
Link to the warning 👉 https://t.co/nH38uaX534
#regulatoryaffairs #medtech #dataresearch #datacollecting #clinicaldata #EU #UDI #notifiedbodies

[MsAmyLewis @MsAmyLewis]

How we talk about masking matters! I made some posters I hope will help our community embrace mask wearing - please feel free to download and print, or send to any organisations who may use them Download ➡️ https://t.co/9drKzKH8s8

#wearamask #maskup #COVIDisAirborne #auspol