QMS Essentials for MedTechs in 2025
In this post, rather than talking about Quality Management Systems (QMS) in general, we will go…
Navigating FDA Cybersecurity Requirements for Medical Devices – A Case Study
This case study describes the experience of a multinational medical device manufacturer meeting the FDA cybersecurity…
Information Security (ISO 27001) Risk Management Best Practices for 2025
Keeping your data safe is vital for every business. One way to do this is by…
NIS2 and DORA Compliance and Protecting your Atlassian Cloud Data
This is a guest-article from Atlassian Marketplace Partner, Revyz In late 2022, the European Parliament introduced…
Supporting Regulated Industries on Atlassian
On May 2, 2024 SoftComply hosted the 2nd edition of Regulated Industries workshop during Atlassian Team…
What are the FDA 21 CFR 11 Compliant Electronic Records?
Title 21 of the Code of Federal Regulations, Part 11, also known as 21 CFR 11,…
What is an FDA 21 CFR 11 Compliant Electronic Signature?
Title 21 of the Code of Federal Regulations, Part 11, also known as 21 CFR 11,…
Demystifying Software Tool Validation
Ever wondered why software tool validation is crucial in the medical device industry? With modern medical…
Don’t Leave Your Quality Team Behind!
Your Development team might find the instructions from Quality and Compliance team time-consuming – slowing down…
End App Fatigue with one Risk Management Solution
For decades organisations have been struggling with working in silos with different departments working with several…
Turning Confluence Cloud into a Compliant Document Management System
SoftComply Document Manager is the newest Confluence Cloud app for managing documents with dedicated Workflows and…
The Document Management Solution You Have Been Waiting For: THE SOFTCOMPLY DOCUMENT MANAGER
TL;DR INTRODUCTION Choosing the appropriate document management system for your company is a critical task. You…