Regulatory Challenges for AI-Enabled Medical Devices

White paper on Artificial Intelligence and Auto-Injectors

QMSR and FDA QSR & ISO 13485 Harmonization

Regulatory Compliance for AI-Enabled Medical Devices

Medical Devices Cybersecurity Checklist

Medical Devices Threat Modeling

New confinis Cybersecurity Services

(EU) 2023/607, 26th May 2024 deadline approaching

The Future of Health Grant welcomes confinis as a new Program Partner

Transitioning to the Medical Device Regulation (MDR) 2017/745

Deadline for transitioning to the Medical Device Regulation

A Step Forward in Medical Device Manufacturing: the New QMSR Aligned with ISO 13485:2016

Leveraging Real-World Evidence: Insights and Guidance for Medical Device Manufacturers

confinis ag appoints Dario Motti as lead of new Digital Health Competence Cluster

Change in Management Structure with Appointment of New CEO at confinis ag

The Medical Device Regulation and the medical care for children and rare diseases

IVD News – IVDR Date of Application, new Guidance Documents

Electromagnetic Compatibility (EMC) of Medical Devices

IVD News – Progressive Roll-Out and MDCG 2022-2 on Clinical Evidence

UK Responsible Person Services

confinis launches new UK Responsible Person service in UK

ISO/FDIS 11608 series opened for voting

confinis partners with Irdeto to launch the first cybersecurity assessment tool in the medical devices industry

confinis offers Swiss Representative Service

Exporting Swiss Medical Devices to the EU

Join our Startup Workshop 2021!

Bei Medizinprodukten auf die EU warten hilft der Schweiz wenig

Clinical and Performance Evaluation – our 5 strengths at your service