The Ultimate Guide to ISO 14971 Risk Management

Who Is This Guide For? At SoftComply, we understand the importance of proper risk management. From costly design changes to product recalls and bad press, not accounting for risks is in fact the single biggest gamble that companies are taking today. If you are a medical device manufacturer, marketer, designer, or anyone connected with the […]

Doccle: How an Integrated Risk Management System paved the road to ISO27001 compliance

Doccle, a leading IT service provider in Belgium that specializes in helping businesses transition to 100% digital invoice administration realized that one of their own central processes – risk management – was not yet fully digitalized. They started a search for an integrated, efficient, and compliance-ready risk management solution within their existing Jira and Confluence […]

How to Prepare for ISO 27001 Compliance in Jira Cloud

Like with any compliance journey, you should first establish why you need to be compliant with a certain regulation. ISO 27001 certification is widely used to build trust and credibility with customers and stakeholders. Similarly, in the Atlassian ecosystem, the requirement of obtaining ISO 27001 certificate applies to Marketplace Partners that wish to retain their […]

Introducing Advanced Cybersecurity Risk Management on Jira Cloud

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, where medical devices are made […]