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In Search of a Compliance Solution that Lets You Sleep at Night
How to find the best regulatory compliance solution for medtech on Atlassian
Validation
Validation of Cloud Software Tools – an Introduction
Overview Modern medical device regulations are putting more and more emphasis on the management of software…
FDA Software Assurance
On the New FDA Guidance on Software Assurance
On September 13 2022, the FDA issued a new draft guidance on “Computer Software Assurance for…
Capture&Freeze
How to Maintain a Documentation Baseline of Agile Development in Confluence?
most popular use cases for capturing and freezing the always dynamic data in Confluence with the SoftComply Static Snapshots app
change management
Change Management & Medical Device QMS on Confluence
How to keep your QMS up to date when regulations and standards change over time with the help of a Compliance Matrix
Display approval
Display Document Approvals on Confluence Pages with the SoftComply Change History app
display your document approval history on Confluence pages with the SoftComply Change History app
Cloud_eQms_logo_Final-02
Introducing the Cloud eQMS Solution for Confluence
Why Confluence? Or perhaps the first question should be – why quality management? Most medical device…
Create-New-selection
How to Manage Software Risks in Jira?
Perhaps the question we should ask first is: WHY MANAGE RISKS IN JIRA? A growing number…
SafetyCriticalSoftware@2x
Six Must-Have Atlassian Cloud Apps for the Regulated Industries
Introduction With Atlassian’s Server end of life approaching in a few years, most companies need to…
Requirements-Jira-Confluence
How to Manage Requirements in Confluence and Jira
Introduction to Requirements Management in Jira and Confluence Requirements management in the regulated domains such as…
FDA-ISO13485
Relationship between FDA & ISO 13485
The relationship between the FDA and ISO 13485 goes back a long time. The ISO standard…
Jira-reports-on-RM
Risk Management Guide for a Digital Health or a Medical Device Company on Jira Cloud
Why Risk Management Compliant Risk Management is a mandatory regulatory requirement for companies in medical device…