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 decide whether to migrate to Cloud or to Data Center. Data Center may seem like a natural path to take for the larger (over 300 users) companies in the regulated domains. Nevertheless, there are some regulated industries like the […]
How to Manage Requirements in Confluence and Jira
Introduction to Requirements Management in Jira and Confluence Requirements management in the regulated domains such as medtech, automotive or aviation has certain differences compared to the agile development. Jira Software with its easy to use backlog view and work boards suits best for managing requirements in the agile world. For the regulated domains it might […]
Risk Management Guide for a Digital Health or a Medical Device Company on Jira Cloud
Why Risk Management In the fast-paced world of medical device development, safety and quality are of utmost importance. Manufacturers must adhere to stringent regulations and standards to ensure that their devices are safe and effective for patients. One such standard that plays a crucial role in the medical device industry is ISO 14971, which focuses […]
How to Build a Risk Analysis in Jira
How to build a risk analysis in Jira with the SoftComply Risk Manager app
How to apply SoftComply Risk Manager features to any Jira project
Wouldn’t it be cool to keep everything in Jira – your backlog, your test cases and your risks all in Jira? Yes, but you could do that for years already. But what if all that can be done in a single Jira project? That would be truly awesome! You can now do it with the […]
Why Decompose the Probability of Harm in two – P1 and P2
P1 and P2 No we are not talking about the early Playstation versions… ISO 14971 (2019 version, Annex C) indicates that the probability of a Harm occurring can be decomposed in two probabilities, P1 and P2, where: P1 = Probability of Hazardous situation occurring P2 = Probability of Harm occurring for a given Hazardous situation […]
What is a Risk Management File?
ISO 14971:2019 defines the Risk Management file as a “set of records and other documents that are produced by risk management”. In practice, the risk management file must contain, or have reference to, the following documents: (4.2, Note 3) The policy for establishing criteria for risk acceptability. (4.4) The Risk Management Plan. (4.5) Traceability for […]
Comparison of Risk Management Apps on Jira Cloud
Following our previous post where we compared the 4 top risk management apps on Jira Server, in this post we are comparing the features of the 2 most popular risk management apps on Jira Cloud. One of them is for product and project risk management (SoftComply Risk Manager) and the other for organisational risk management (Risk […]
What are the best Risk Management Apps on Jira & how they compare to each other?
In the following post we compare the features of 4 top risk management apps on Jira Server. Comparison of risk management apps on Jira Cloud can be viewed here. There are four popular apps on Jira Server for risk management purposes. Two of them are for product risk management and the other two for project […]
IEC 60601 – Essential Performance, Safety and Risk Management
Background IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment. Although if focuses primarily on electromechanical devices, it also applies to aspects of the software components. It is a widely recognized standard that most, if not all, medical device companies have to comply with. The concept […]
