Marion Lepmets _SoftComply_ Community Champion

Hazard analysis is the must-have risk management approach in medical device industry. While many companies stick with single probability values in their hazard analysis, ISO 14971 suggests breaking down probability into P1 and P2 components to make medical device risk management more precise. I’ll show you exactly how to…

Risk management in the medical device industry isn’t optional – it’s literally life or death. If you’re developing medical devices, you need to identify, assess, and mitigate risks throughout your entire product lifecycle. Patient safety depends on it. Watch this step-by-step guide to implementing FMEA for medical device…

Medical device risk management isn’t just another regulatory checkbox. It’s the foundation that proves your device is safe for patients and users. When auditors come knocking, they’ll scrutinize your risk management process more than almost anything else. Get it wrong and you’re looking at serious compliance issues. I’ve…

For regulated industries - such as Pharma, MedTech, FinTech and Aviation - compliance isn't optional; it's mandatory. Tools like Jira and Confluence are powerful, but their true potential is only realized when configured to meet industry-specific regulatory requirements. This is where industry consultants come into play,…

The EU AI Act is here – the world’s first major AI regulation, reshaping how companies build and use intelligent systems. For medical device software, this means tighter rules, higher expectations, and a major shift in how they approach compliance. The AI Act categorises systems by risk and bans certain practices –…

In the medical device industry, risk management is not just a regulatory requirement. It is a fundamental practice to ensure the safety, effectiveness and quality of devices that directly impact patient health and wellbeing. If you operate within the medical device industry as a manufacturer, Software as a Medical Device…

Compliance is (finally) on everyone’s mind now that Atlassian is targeting business teams and business users in specific verticals and focusing more on solutions rather than apps. This is also why SoftComply hosted the 3rd edition of the Compliance Workshop on April 10, 2025 during Atlassian Team event. The workshop’s…

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 field…

What is a Risk Register and Where to Build It? Risk Management is an essential governance practice for enterprise, product, portfolio, information security and project management. Proactive risk management ensures that the most significant risks that could impact the organization’s objectives are effectively mitigated. The…

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…

Being an ISO 27001-compliant company means that you protect your information assets and client data against possible data breaches. It supports your business growth as it builds trust in your company and your products. In the hopes of achieving ISO 27001 compliance quickly, many companies purchase a huge ISO 27001…

Disasters don’t happen by accident—they happen when risks go unmanaged. 🚨 In safety-critical industries like aviation and healthcare, the cost of poor risk management can be catastrophic. Join us on March 27th as industry experts discuss: * major organisational failures, * the lessons they leave behind, * how proactive…

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…

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…

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…

There are some electronic records that a medical device manufacturer can easily manage in Confluence while others require a compliant document management solution. This post describes which records fall under regulations and which don't. From FDA 21 CFR 11.3(b)(6) “Electronic Record means any combination of text, graphics,…

All product development teams let out a sigh of relief when a product is launched. The hard technical work is done, tight deadlines met (more or less), submissions completed and approved. Time to hand over to the sales and marketing group and take a well deserved break. But other parts of the company, even in the…

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…

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…

Join us on September 11th at 4pm CET for an online webinar on Document and Quality Management in Confluence & how to validate your Confluence Cloud instance. 

Integrating risk management into the Software Development Lifecycle (SDLC) of a product is crucial to its success. It enhances the safety, security and reliability of your software product. When you identify, assess, and mitigate risks early, you can avoid bigger problems down the line. Think of it as a systematic…

What is CVSS and when to use it? The Common Vulnerability Scoring System (CVSS) is a standardized framework for rating the severity of security vulnerabilities. The CVSS was developed and is maintained by the Forum of Incident Response and Security Teams (FIRST). FIRST is an international consortium that aims to foster…

Hazard analysis is crucial in safety-critical product development, especially for medical devices. You can conduct hazard analysis also in Jira - check out the guide below. If you prefer to watch the video instead of reading, you can do so here. Key Takeaways: * Hazard analysis helps assess potential hazards, hazardous…

If you’re considering using Excel for your Risk Register, this video explains why that might not be the best choice. Instead, we introduce a more effective alternative using Jira and dedicated risk management plugins. If you prefer watching over reading, check out the full video. Key Takeaways: * Excel Limitations: Manual…

In this article, we will look at the 4 steps needed to build a Risk Register in Jira. For those of you fluent in Jira, this tutorial will be focusing on risk lifecycle management not the native Jira issue workflows. What is a Risk Register and why create it in Jira? The document where an organization or a risk manager…

A risk manager continuously identifies, assesses, and mitigates potential risks that could impact an organization’s objectives. They develop strategies to minimize threats, ensure compliance with regulations, and protect company’s financial stability and reputation. Very often there is no one person called Risk Manager in…

Biome Diagnostics GmbH is an Austrian medtech start-up utilizing the genetic information of the microbiome and AI to develop medical diagnostic software for doctors. Biome Dx products utilize technologies such as next-generation sequencing, pipeline architectures and microservices. With their lifestyle…