global consulting firm in the field of medical devices, IVDs, and combination products (regulatory affairs, quality management, design control, project mgmt)
Joined March 2016
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Swissmedic published info regarding the CH REP: bit.ly/3cTNoXD
Transition periods :
class III and class IIb implantable: 31 Dec 21
class IIb (not implantable) and IIa : 31 Mar 22
class I : 31 Jul 22
Pls contact us if you require CH REP and/or PRRC services!
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Innovation Council has approved #brayZ Innosuisse application with the title b-box: a stand-alone AI platform for breast cancer imaging. rb.gy/mvtvlg
This project rocks and we are thrilled to contribute!
#machinelearning #aiinhealthcare #breastcancer #digitalhealth
The Swiss Notified Body SQS published a helpful tool on their website to analyze the effect of significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD: lnkd.in/dtm6S6z
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POLITIK SCHALTET SICH BEI MEDIZINPRODUKTEN EIN
Die Schweiz kann sich bei Medizinprodukten nicht auf die unsichere und noch lange andauernde europäische MDR-Einführung verlassen.
Link zur Motion von D. Müller: lnkd.in/g2uh3_Y
Eine Einschätzung: lnkd.in/ghnKnta
Swiss Medtech Umfrage: Export in die EU mit Drittstaatanforderungen sichern. Eine lesenswerte Zusammenfassung und Interpretation von Peter Studer (Senior Advisor, confinis ag) gibt es hier: bit.ly/2KPLYih
"MDR Support Panel - Combination Products"
- are you already registered? Dr. Thomas Feldmann, DQS, and Adrian Gammeter, @byConfinis, will be addressing Article 117 sway.office.com/fwtwedE4346L…
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Do you visit the MedtecLIVE? The confinis booth: hall 10 No 232
- mailchi.mp/ceb08ef76266/do-y…
Register with 30% discount and "Sharpen your Skills" - Medical Device Development in the EU MDR era! - Zürich 21.05.2019 - mailchi.mp/7c0dc8030819/regi…
You are a subject matter expert in #regulatoryaffairs or #qualitymanagement for #medicaldevices, #invitrodiagnostics or #combinationproducts and like to work independently, but still connected to a team of peers in your field? check options @byConfinis : confinis.com/independent-pro…
Continuing the blog posts with regard to the implementation of the European #MDR, the article by Adam Freeman and the presentation by Frank Blömer put a focus on the requirements for audits and also shows the links to the #MDSAP program.
confinis.com/regulations/eu-…
Like a lot of things in our rapidly changing world, we’ve grown.
We are happy to announce, that @byConfinis is moving to its new office location in Sursee, the heart of Switzerland!
@byConfinis is looking for you! we want to expand our team! If you are the subject matter expert in regulatory affairs and quality management, check out your opportunities: confinis.com/careers_archive… and
confinis.com/independent-pro…
Some food for the brain after the festive days. Check out the blog-post by Urs Widmer, Senior Consultant at @byConfinis about GSPRs - MDR - 2017/745 - confinis.com/regulations/gsp…
What is crucial information for the Technical Documentation of your #medicaldevice regarding #compliance with the European MDR? Read the blog-post by Nicole Gabathuler, Senior Consultant at #confinis - confinis.com/regulations/tec…
BVMed - Bundesverband Medizintechnologie - BVMed zur ARD-Doku "Außer Kontrolle" und "Hart aber fair": "Die… bvmed.de/de/bvmed/presse/pre…
Classification of medical devices under the European Medical Device Regulation 2017/745 - by Joachim Makowski
Read more: confinis.com/confinis/classi…
Work in progress regarding MDR implementation - confinis and its partners - Transition periods and definitions - all clear? Check out the information provided by Ulrich Schanke and Bernd Juhre - mailchi.mp/e93e14e5029b/your…
confinis - smarter clinical project management - serving the health technology industry for the entire product lifecycle - mailchi.mp/8b0a5db78334/conf…
