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 […]
Why ISO27001 Should Stay Within Jira for Atlassian Marketplace Partners
Atlassian’s updated Marketplace Partner Program underscores the need for robust security management. With increasing customer expectations around data protection, security, and compliance transparency, Gold and Platinum Marketplace Partners are required to demonstrate adherence to compliance framework like SOC 2 or globally recognised standards such as ISO 27001. This shift is particularly critical for vendors managing […]
What does FDA Guidance on Predetermined Change Control Plan mean for Medical Device Manufacturers?
Intro FDA aims to provide a regulatory framework that supports innovation in medical device software development. As such, they understand the need to rapidly change and update software without affecting the safety and effectiveness of the device. In such cases, a new submission shouldn’t always required. But when? Overview In August 2024 the FDA release […]
AI-enabled Medical Devices – FDA Guidance
Intro Medical Devices that contain AI-driven functions have been the focus of Regulatory Agencies in both the EU and the US for the past 2 years, with the FDA taking the lead in releasing regulations and guidance on the matter. On January 6, 2025 the FDA released a new Draft Guidance “Artificial Intelligence-Enabled Device Software Functions: […]
ISO 13485 Implementation Guide for Startups in 2025
The Internet is full of articles about the implementation of ISO 13485. They talk about “Getting management support”, “Obtain The Documents And Study The Requirements”, “Develop An Implementation Plan”, “Evolution of a Quality Management System”, and other seemingly complex topics. Although comprehensive, most of these articles are self-serving, aimed at promoting specific services of the […]
Software as a Medical Device (SaMD) Startup Guide to Compliance for 2025
Introduction The first contact with the Medical Device regulatory world is a shock for most startups. These companies usually have excellent technical and clinical ideas on how to improve the patient’s life, but little knowledge of the legal burdens required to bring the medical device to the market. The technical world of reasonable certainties clashes […]
18 e-Signature Apps in Confluence Cloud (Comparison for 2025)
What is an “Electronic Signature”? Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature. (21 CFR 11.3) In other words, to Electronically Sign a document means to execute of a series of […]
How a Compliance Solution on Atlassian Cloud Empowered a Leading MedTech Company
A mid-sized company in the medical technology sector faced a growing challenge: meeting the stringent requirements of the Medical Device Regulation (MDR) and FDA 21 CFR. As the company expanded, the existing ways of managing risks and documentation – such as Excel spreadsheets and paper-based processes – became increasingly inefficient and error-prone. This not only […]
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 requirements. The company is operating in the MedTech sector developing a class 2/IIb device consisting of hardware and software. The company spent about 2 years working on the security risk management of the device. In addition, they also embarked […]
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 following ISO 27001. But how can we manage these information security risks with a tool like Jira? Let’s dive in! What is Information Security Risk Management Information Security Risk Management is all about identifying, assessing, and managing risks to […]
