FDA service request

06/10/2025 -

White Paper on Audits from a Lead Auditor’s Perspective

21/08/2025 -

White Paper on sustainability in the medical device industry

10/07/2025 -

RAPS Global Board Director Nomination Announcement

01/07/2025 -

White Paper on MDCG 2019-11 REV.1 update

15/04/2025 -

FDA Regulatory Pathways online course

30/01/2025 -

White Paper on ISO 42001:2023 and AI-Driven Medical Devices

26/01/2025 -

confinis Academy Launch

17/01/2025 -

White Paper on FDA’s Draft Guidance for AI in Healthcare

13/01/2025 -

White Paper on Post-Market Surveillance and Vigilance

09/12/2024 -

Aligning ISO 13485 with MDR

05/11/2024 -

Regulatory Challenges for AI-Enabled Medical Devices

31/10/2024 -

White paper on Artificial Intelligence and Auto-Injectors

15/10/2024 -

QMSR and FDA QSR & ISO 13485 Harmonization

07/10/2024 -

Regulatory Compliance for AI-Enabled Medical Devices

23/09/2024 -

Medical Devices Cybersecurity Checklist

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

31/08/2021 -

What is an IVD?

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

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