Software Tool Validation in the Medical Device Industry – A White Paper
Marion Lepmets
CEO
March 6, 2023
Table of Contents
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Matteo Gubellini
Regulatory Affairs Manager
January 20, 2025
Intro Medical Devices that contain AI-driven functions have been the focus of Regulatory Agencies in both the EU and the US for the past 2 years, with the FDA taking the lead in releasing regulations and guidance on the matter. On January 6, 2025 the FDA released a new Draft Guidance...
Marion Lepmets
CEO
December 18, 2024
The Internet is full of articles about the implementation of ISO 13485. They talk about “Getting management support”, “Obtain The Documents And Study The Requirements”, “Develop An Implementation Plan”, “Evolution of a Quality Management System”, and other seemingly complex topics. Although comprehensive, most of these articles are self-serving, aimed at...
Matteo Gubellini
Regulatory Affairs Manager
December 3, 2024
Introduction The first contact with the Medical Device regulatory world is a shock for most startups. These companies usually have excellent technical and clinical ideas on how to improve the patient’s life, but little knowledge of the legal burdens required to bring the medical device to the market. The technical...
