Analyses réglementaires

Articles d’experts sur l’EU MDR, la FDA, l’IEC 62304 et la stratégie réglementaire pour les fabricants de dispositifs médicaux

Design ControlsDHFEU MDRFDAProduct Development

Design History File Remediation: A Practical Guide for Medical Device Manufacturers

Learn when and how to remediate your Design History File (DHF) to satisfy FDA 21 CFR 820.30 and EU MDR Annex II requirements, with strategies for legacy devices and regulatory transitions.

Dr. Martin Walter8 mars 2026

21 min read

ISO 13485QMSQuality ManagementCompliance

ISO 13485 QMS Implementation Guide: Building a Compliant Quality Management System for Medical Devices

A comprehensive guide to implementing ISO 13485:2016, covering scope determination, process approach, design controls, CAPA, supplier management, and MDSAP alignment for medical device manufacturers.

Dr. Martin Walter8 mars 2026

22 min read

CybersecurityIEC 81001-5-1IEC 62443FDASoftware

Medical Device Cybersecurity Compliance: From Threat Modeling to Market Access

A comprehensive guide to cybersecurity compliance for connected medical devices, covering IEC 81001-5-1, FDA expectations, threat modeling, SBOM requirements, and post-market vulnerability management.

Barry Keenan8 mars 2026

20 min read

EUDAMEDEU MDRUDIComplianceMedical Device Registration

EUDAMED Registration Guide 2026: Complete Walkthrough for Medical Device Manufacturers

A comprehensive guide to EUDAMED registration ahead of the May 2026 mandatory deadline. Covers all six modules, Actor Registration, UDI submission, and practical steps for compliance.

Dr. Martin Walter8 mars 2026

15 min read

EU MDRRegulatory StrategyComplianceDeadlines

EU MDR Transition Deadlines 2026-2028: Critical Dates Every Manufacturer Must Know

Complete timeline of EU MDR transition deadlines from 2026 to 2028, including extended transition conditions, EUDAMED milestones, Notified Body capacity, and a practical month-by-month action plan for manufacturers.

Dr. Martin Walter7 mars 2026

11 min read

Post-Market SurveillanceEU MDRPMCFPSURCompliance

Post-Market Surveillance Under EU MDR: A Complete Guide to PMS, PMCF, and PSUR

Comprehensive guide to post-market surveillance under EU MDR 2017/745, covering PMS plans, PMCF studies, PSUR requirements, EUDAMED vigilance reporting, and practical implementation strategies.

Dr. Martin Walter6 mars 2026

14 min read

UDISwissdamedSwitzerlandComplianceMedDOSwissmedic

Swiss UDI Mandate and Swissdamed: What Manufacturers Need to Know

A comprehensive guide to Switzerland's UDI requirements, Swissdamed registration, CHRN obligations, and how the Swiss framework differs from EU MDR and EUDAMED for medical device manufacturers.

Dr. Martin Walter5 mars 2026

12 min read

Clinical EvaluationEU MDRCERClinical Affairs

How to Write a Clinical Evaluation Report (CER) Under EU MDR: A Practical Guide

A comprehensive guide to writing Clinical Evaluation Reports under EU MDR 2017/745, covering MEDDEV 2.7/1 Rev 4 methodology, equivalence claims, literature searches, and common Notified Body rejection reasons.

Barry Keenan4 mars 2026

15 min read

CE MarkingEU MDRTechnical DocumentationCompliance

CE Marking for Medical Devices: The Complete EU MDR Guide (2026)

A comprehensive guide to CE marking medical devices under EU MDR 2017/745. Covers classification, conformity assessment routes, technical documentation, and common pitfalls.

Dr. Martin Walter2 mars 2026

16 min read

EU MDRRegulatory StrategyCompliance

EU MDR Implementation: What Manufacturers Need to Know in 2026

The EU Medical Device Regulation (MDR 2017/745) has reshaped the European medical device landscape. With extended transition deadlines approaching and EUDAMED milestones on the horizon, manufacturers must act now to secure market access.

Dr. Martin Walter3 février 2026

10 min read

FDAEU MDRCE MarkingRegulatory Strategy

FDA 510(k) vs EU MDR CE Marking: A Comparative Guide

Manufacturers targeting both the US and European markets must navigate two fundamentally different regulatory frameworks. This guide compares the FDA 510(k) pathway with EU MDR CE marking to help you plan a dual-market strategy.

Barry Keenan20 janvier 2026

9 min read

IEC 62304SoftwareCybersecurity

Getting Started with IEC 62304: A Practical Guide for Software Teams

IEC 62304 defines the lifecycle processes required for medical device software development. This practical guide breaks down the standard, explains software safety classification, and highlights common pitfalls to help your team achieve compliance efficiently.

Dr. Martin Walter8 janvier 2026

11 min read

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