Software Tool Validation in the Medical Device Industry – A White Paper

March 6, 2023

WHITE PAPER ON REGULATORY REQUIREMENTS AND BEST PRACTICES FOR VALIDATION



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Table of Contents

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SaMD Guide to Compliance
Picture of Matteo Gubellini

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...

e-signature
Picture of Matteo Gubellini

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...

New Cybersecurity Risk Management Features in Jira
Picture of Marion Lepmets

Marion Lepmets

CEO
November 8, 2024

The Role of Cybersecurity in Medical Device Safety The Global medical device market is a $800 billion business that is rapidly growing, especially in the area of software as a medical device (SaMD). The majority of the SaMD segment is made up of the digital health and digital therapeutics solutions,...