Part of Athagoras

EUDAMED Devices Registration

Regulatory Pathway for Combination Products

AI Under Joint Regulatory Scrutiny

The Swissdamed registration deadline is approaching

Drug-device combinations regulatory pathway

Insulin delivery as an integrated ecosystem

Regulatory rescue for manufacturers

AI doesn’t just hallucinate… it agrees.

Medical devices regulatory guidance with confinis

Can AI write Technical Documentation?

JPM Healthcare 2026

Usability for Combination Products

AI and Medicine Development

AI and Regulatory Conformity

Why did adaptive DBS scale so well in Europe?

Automated Insulin Delivery as a Regulated Ecosystem

A Meaningful Year for confinis

White Paper on Audits from a Lead Auditor’s Perspective

White Paper on sustainability in the medical device industry

RAPS Global Board Director Nomination Announcement

White Paper on MDCG 2019-11 REV.1 update

FDA Regulatory Pathways online course

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

confinis Academy Launch

White Paper on FDA’s Draft Guidance for AI in Healthcare

White Paper on Post-Market Surveillance and Vigilance

Aligning ISO 13485 with MDR

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

The EU Artificial Intelligence Act and Medical Device Regulation with Andrea Biasiucci

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

Working at confinis and the IVDR world with Barbara Jeroncic

IVD News – IVDR Date of Application, new Guidance Documents

confinis and deep tech with Andrea Biasiucci

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

What is an IVD?

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!

… and Report your Post-Market Clinical Follow-up Evaluation!

How to plan your post-market clinical follow up…

How does the notified body assess your clinical evaluation?

How to perform a clinical evaluation for Medical Device Software

How to ensure sufficient clinical evidence for legacy devices

How to claim an equivalence in the clinical evaluation under the MDR

Novelties for Clinical Evaluation and Post Market Surveillance within MDR – the Posts Series

Bei Medizinprodukten auf die EU warten hilft der Schweiz wenig

Clinical and Performance Evaluation – our 5 strengths at your service

confinis partners with b-rayZ concerning innovative Artificial Intelligence project

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

Revision der Schweizer Medizinprodukteverordnung mit Folgen

Workshop: Software as a Medical Device (SaMD) in Zürich

Interpellation Jacqueline de Quattro on medical devices

confinis celebrates 15th anniversary

Web based tool to analyze effect of significant changes to devices covered by MDD or AIMDD certificates

Politics intervene regarding medical devices

Development of medical devices to tackle COVID-19 – UPDATE

Swiss Medtech Umfrage: Export in die EU mit Drittstaatanforderungen sichern

Peter Studer joins confinis as Senior Advisor

EU MDR audit requirements and links to MDSAP program

From “Essential Requirements” to “General Safety and Performance Requirements” – EU MDR 2017/745

Technical Documentation for medical devices under the new European MDR

Conformity Assessment Procedures and Premarket Scrutiny under EU MDR

Classification of medical devices under the European Medical Device Regulation 2017/745

#MDR – Transition periods and definitions

Work in progress: MDR implementation – impact on your Quality Management System (ISO 13485:2016)

Your insight to: confinis and its partners – work in progress regarding MDR implementation

MDR Article 117 – a look into the Crystal Ball (Part 6)

From Investigator to Consulting: On the other side of the fence

MDR Article 117 – a look into the Crystal Ball (Part 5)

WORKSHOP: PMS under the new European MDR

“Quick Wins” for your MDR implementation

MDR Article 117 – a look into the Crystal Ball (Part 4)

MDR Article 117 – a look into the Crystal Ball (Part 3)

MDR Article 117 – a look into the Crystal Ball (Part 2)

MDR Article 117 – a look into the Crystal Ball (Part 1)

confinis opens US office in the Washington DC area

MDR Article 117 – are Combination Product Manufacturers prepared?

New year, new energy!

Beat Steffen to speak at Medtech & Pharma Platform in Basel

Upcoming ISO Technical Report regarding Post Market Surveillance

Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR): Impact on Switzerland

Why did adaptive DBS scale so well in Europe?

Why did adaptive DBS scale so well in Europe?
It’s easy to point to the technology. But the more interesting story is how it was positioned.

Medtronic’s adaptive DBS systems respond to patient signals in real time, using sensing-enabled feedback loops embedded in an implantable neurostimulator, a capability described in peer-reviewed clinical studies and reflected in CE-marked system documentation (e.g. BrainSense™ technology, EU technical documentation; clinical publications in Brain and The Lancet Neurology).

Crucially, the system was framed as adaptive, not autonomous, with clinical decision-making remaining with the clinician.

That distinction appears consistent with current interpretations of how European regulators assess AI-assisted functions under the MDR.

In practice, scalability came from:

🟥 tightly defined intended use (MDR Annex I principles)
🟥 early alignment of claims with clinical evidence (MDR clinical evaluation expectations)
🟥 governance of algorithmic behavior without continuous self-learning

The algorithm mattered, but the regulatory framing around it mattered just as much.

How do you draw the line between adaptive support and autonomy in your own products?

While you focus on innovation, we take care of the regulatory path!