May 11, 2026
AI/ML Systems, preparing an FDA submission – Part I: ‘Initial Strategy’
Summary FDA submissions for AI/ML-enabled medical devices rarely fail because of a single mistake – they unravel due to a
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August 1, 2025
Regulatory Challenges for Medical Device Distributors in the EU
Where the European Medical Device Regulations (MDR 2017/745 & IVDR 2017/746) have significantly increased the regulatory burden for Legal Manufacturers
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October 28, 2024
EUDAMED: Current Status, Timelines, and Implementation Guide
Co-authored with Preethi Philip Under the MDD 93/42/EEC, the medical device industry lacked a serious level of transparency in the
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September 30, 2024
MHRA Unveils Key Changes to Medical Device Regulations
The latest MHRA update outlines significant regulatory reforms in the medical device industry, with the goal of enhancing patient safety
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September 11, 2024
Swissdamed’s Actors Module Goes Live & Switzerland Embraces EU IVDR Amendments
The Actors module of the Swissdamed medical devices database is currently operational as of August 6, 2024. This module facilitates
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August 22, 2024
Who Is a Medical Device Distributor and What Should You Be Aware of?
Under the MDD 93/42/EEC, the role of the medical device Distributor was largely unaddressed in the Medical Device legislation within
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August 1, 2024
The EU AI Act Countdown Starts Now!
Today marks an important milestone for the European Union (EU). After a three year development period, the EU AI Act
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July 30, 2024
AI Act Meets MDR & IVDR: How Aligned Are They? A Comprehensive Overview
As we prepare for the AI Act to take effect on August 1, 2024—20 days after its publication in the
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June 6, 2024
Understanding the Role of the PRRC in Medical Device Compliance
Regulations are becoming more stringent by the day, with increased safety requirements for medical device manufacturers under the Medical Device
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