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 […]
How to Turn Confluence into a Compliant Document Management System for Medical Devices
WHY CONFLUENCE? Most medical device companies need to have at least a compliant quality management system in place, not to mention the quality records that will always need to be generated during the lifecycle of the device. With your software development team using Jira, it is natural that your organisation would like to have everything […]
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 SoftComply eQMS & MediCompli Solution
What is a Quality Management System? You probably know that Medical Device companies are required to have a Quality System in place, in order to be able to market their products in most countries in the world. This Quality System, or Quality Management System – QMS, is a collation of Procedures, documents, templates and records […]
How to Create an Organisational Risk Register with SoftComply Risk Manager?
Abstract The aim of this blog post is to guide you through the creation of an organisation-wide Risk Register with SoftComply Risk Manager. This Risk Register supports risk management across your organisation providing your team members with a list of risks that apply to a specific product or project. To achieve that, we will first […]
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 […]
SoftComply offers Free Apps to get More Ventilators and Test Kits for COVID-19 to Market Faster
Medical equipment at the Columbus Covid-2 Hospital, in Rome, on March 16, 2020 from The Globe and Mail With the lack of medical equipment in light of the rapid spread of COVID-19 and the hospitalization of infected people (1), SoftComply offers their support to medical device companies. Medical device companies are currently working non-stop to […]
SoftComply at Atlassian Summit 2020
Let’s meet up & talk about Compliance on Atlassian Stack! Tue, 31 Mar 2020 – Thu, 02 Apr 2020 SoftComply Stand: 1319 We support regulated industries on Atlassian stack by offering compliance solutions and services on Atlassian Jira and Confluence.