06/08/2024 -
Medical Devices Threat Modeling
 
23/07/2024 -
New confinis Cybersecurity Services
 
24/05/2024 -
(EU) 2023/607, 26th May 2024 deadline approaching
 
23/05/2024 -
The Future of Health Grant welcomes confinis as a new Program Partner
 
01/05/2024 -
Transitioning to the Medical Device Regulation (MDR) 2017/745
 
11/04/2024 -
Deadline for transitioning to the Medical Device Regulation
 
13/03/2024 -
A Step Forward in Medical Device Manufacturing: the New QMSR Aligned with ISO 13485:2016
 
08/03/2024 -
The EU Artificial Intelligence Act and Medical Device Regulation with Andrea Biasiucci
 
21/02/2024 -
Leveraging Real-World Evidence: Insights and Guidance for Medical Device Manufacturers
 
07/09/2023 -
confinis ag appoints Dario Motti as lead of new Digital Health Competence Cluster
 
03/07/2023 -
Change in Management Structure with Appointment of New CEO at confinis ag
 
02/12/2022 -
The Medical Device Regulation and the medical care for children and rare diseases
 
09/11/2022 -
Working at confinis and the IVDR world with Barbara Jeroncic
 
07/07/2022 -
IVD News – IVDR Date of Application, new Guidance Documents
 
15/06/2022 -
confinis and deep tech with Andrea Biasiucci
 
10/06/2022 -
Electromagnetic Compatibility (EMC) of Medical Devices
 
22/02/2022 -
IVD News – Progressive Roll-Out and MDCG 2022-2 on Clinical Evidence
 
20/12/2021 -
UK Responsible Person Services
 
11/10/2021 -
confinis launches new UK Responsible Person service in UK
 
08/10/2021 -
ISO/FDIS 11608 series opened for voting
 
06/07/2021 -
confinis partners with Irdeto to launch the first cybersecurity assessment tool in the medical devices industry
 
18/06/2021 -
confinis offers Swiss Representative Service
 
26/05/2021 -
Exporting Swiss Medical Devices to the EU
 
24/04/2021 -
Join our Startup Workshop 2021!
 
23/04/2021 -
… and Report your Post-Market Clinical Follow-up Evaluation!
 
10/03/2021 -
How to plan your post-market clinical follow up…
 
18/02/2021 -
How does the notified body assess your clinical evaluation?
 
28/01/2021 -
How to perform a clinical evaluation for Medical Device Software
 
15/01/2021 -
How to ensure sufficient clinical evidence for legacy devices
 
21/12/2020 -
How to claim an equivalence in the clinical evaluation under the MDR
 
10/12/2020 -
Novelties for Clinical Evaluation and Post Market Surveillance within MDR – the Posts Series
 
03/12/2020 -
Bei Medizinprodukten auf die EU warten hilft der Schweiz wenig
 
29/10/2020 -
Clinical and Performance Evaluation – our 5 strengths at your service
 
16/09/2020 -
confinis partners with b-rayZ concerning innovative Artificial Intelligence project
 
02/09/2020 -
Join us at world’s leading AI in medicine summit!
 
14/08/2020 -
Revision der Schweizer Medizinprodukteverordnung mit Folgen
 
13/07/2020 -
Workshop: Software as a Medical Device (SaMD) in Zürich
 
02/06/2020 -
Interpellation Jacqueline de Quattro on medical devices
 
02/06/2020 -
confinis celebrates 15th anniversary
 
13/05/2020 -
Web based tool to analyze effect of significant changes to devices covered by MDD or AIMDD certificates
 
08/05/2020 -
Politics intervene regarding medical devices
 
07/05/2020 -
Development of medical devices to tackle COVID-19 – UPDATE
 
01/05/2020 -
Swiss Medtech Umfrage: Export in die EU mit Drittstaatanforderungen sichern
 
27/04/2020 -
Peter Studer joins confinis as Senior Advisor
 
14/02/2019 -
EU MDR audit requirements and links to MDSAP program
 
27/12/2018 -
From “Essential Requirements” to “General Safety and Performance Requirements” – EU MDR 2017/745
 
20/12/2018 -
Technical Documentation for medical devices under the new European MDR
 
03/12/2018 -
Conformity Assessment Procedures and Premarket Scrutiny under EU MDR
 
12/11/2018 -
Classification of medical devices under the European Medical Device Regulation 2017/745
 
22/10/2018 -
#MDR – Transition periods and definitions
 
22/09/2018 -
Work in progress: MDR implementation – impact on your Quality Management System (ISO 13485:2016)
 
04/09/2018 -
Your insight to: confinis and its partners – work in progress regarding MDR implementation
 
03/09/2018 -
MDR Article 117 – a look into the Crystal Ball (Part 6)
 
03/09/2018 -
From Investigator to Consulting: On the other side of the fence
 
10/07/2018 -
MDR Article 117 – a look into the Crystal Ball (Part 5)
 
29/06/2018 -
WORKSHOP: PMS under the new European MDR
 
26/06/2018 -
“Quick Wins” for your MDR implementation
 
25/06/2018 -
MDR Article 117 – a look into the Crystal Ball (Part 4)
 
19/06/2018 -
MDR Article 117 – a look into the Crystal Ball (Part 3)
 
11/06/2018 -
MDR Article 117 – a look into the Crystal Ball (Part 2)
 
08/06/2018 -
MDR Article 117 – a look into the Crystal Ball (Part 1)
 
03/04/2018 -
confinis opens US office in the Washington DC area
 
06/02/2018 -
MDR Article 117 – are Combination Product Manufacturers prepared?
 
05/01/2018 -
New year, new energy!
 
10/08/2017 -
Beat Steffen to speak at Medtech & Pharma Platform in Basel
 
10/08/2017 -
Upcoming ISO Technical Report regarding Post Market Surveillance
 
15/02/2017 -
Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR): Impact on Switzerland
 

Join us at world’s leading AI in medicine summit!

confinis wants to support the Digital Health revolution and is working to acquire valuable knowledge and experience to support clients participating in this new challenge.

We are very proud to announce that we are one of the sponsors of the Intelligent Health AI 2020 (https://intelligenthealth.ai/), the world’s leading AI in medicine summit series, on September 9th and 10th 2020.

This year the event will be exceptionally hosted online, we have a number of free pass for our clients, feel free to reach on if you would like to have one!

Our CEO and Founder Beat U. Steffen will provide a speech on “How to Overcome Regulatory and Clinical Affairs Challenges in Digital Health and AI” on September 9th at 14:40 until 15:00 on the HEADLINERS STAGE of the event.

Also, you will be able to visit us and discover our skills and expertise in medical devices, combination products, digital health, machine learning and AI on our “virtual booth”.

We will provide a series of presentations according to the schedule below:

September 9th

11:20 – 11:40 : Combination Products according to the European Medical Device Regulation 2017/745 Article 117 (live) – Adrian Gammeter

12:15 – 12:45 : Regulatory all you can eat 1: open live Q&A session – Martina Coscia, Andrea Biasiucci, Andrea Schütz Frikart

15:30 – 15:50 : Live demo of confinis’ Atlassian-based paperless electronic Quality Management System (live) – Stefano Adami

17:00 – 17:20: FDA’s Regulatory Oversight on AI and Digital Health (live)

September 10th

8:30 – 9:00 : Regulatory all you can eat 2: open live Q&A session – Martina Coscia, Andrea Biasiucci, Andrea Schütz Frikart

10:55 – 11:15: Introduction on cybersecurity within the European Medical Device Regulation (live) – Martina Coscia

13:00 – 13:25 How to overcome Regulatory and Clinical Affairs Challenges in Digital Health and AI  (recorded) – Beat U. Steffen, CEO

14:15 -14:40 Clinical evidence and Digital Health (live) – Andrea Biasiucci

16:30 – 16:50 How to overcome Regulatory and Clinical Affairs Challenges in Digital Health and AI  (recorded) – Beat U. Steffen, CEO

We look forward towards meeting you!

The confinis team

subscribe now

interested in regulatory affairs, quality management and news about confinis?