Software Tool Validation in the Medical Device Industry – A White Paper
Marion Lepmets
CEO
March 6, 2023
Table of Contents
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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...
Matteo Gubellini
Regulatory Affairs Manager
November 26, 2024
What is an “Electronic Signature”? Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature. (21 CFR 11.3) In other words, to Electronically Sign a document means to...
