Software Risk Analysis in Medical Devices
In the Medical Device industry software components, whether standalone or as part of a physical device, must follow the same rules as any other component, i.e. ISO 14971 “Medical devices – Application of risk management to medical devices”. BUT .. but there are significant deviations required by IEC 62304 and the GDA guidance document “Content […]
Risk Management of Off-The-Shelf (OTS) Software
Your software is likely to contain a number of components, items, packages, libraries, etc. not developed directly by your company. It may include open-source or purchased software. Unless you have a very close relationship with the developer and access to the source code, these components are black boxes for you. According to IEC 62304, the […]
Hazard Analysis and FMEA: the Most Common Approaches to Risk Management for Medical Devices
What is the difference between Hazard Analysis and FMEA. Which approach should you use. Comparison and examples.
4 Key Reasons Why you should move your Risk Management to Jira
Risk management in the regulated industries is often viewed as a necessary evil, but what if we approached it as a secret weapon instead? It’s a common misconception that risk management slows down innovation and adds unnecessary layers of bureaucracy. Yet, in reality, effective risk management is the linchpin of sustainable growth and resilience, especially […]
4 Steps to ISO 27001 Compliance – Start with Risk Management in Jira
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 requirements checklist and templates for […]
3 Simple Steps to Prioritising your Critical Risks
“It’s a dangerous business, Frodo, going out your door. You step onto the road, and if you don’t keep your feet, there’s no knowing where you might be swept off to.” (B. Baggins) The same applies in business in general – no company operates without risks. For you to have started a business, you have […]
Risks? We don’t have any… 6 Steps to Identify Organisational Risks
More often than not, Risk Managers confess to us that when they ask their colleagues about the critical risks in their department, the answer is: “We have no risks!” This is a problem, since it highlights that the concept – what is a risk – is unclear. We recommend Risk Managers to take an actionable […]
Don’t Leave Your Quality Team Behind!
Your Development team might find the instructions from Quality and Compliance team time-consuming – slowing down their delivery time, but the regulatory standards are put in place to ensure the safety, effectiveness and integrity of products from different industries. There are significant consequences for non-compliance ranging from loss of business and legal penalties to your products being […]
End App Fatigue with one Risk Management Solution
For decades organisations have been struggling with working in silos with different departments working with several stand-alone software tools, each for a specific task. With tools like Jira and Confluence that cater to a variety of different needs you can set up your entire organisation on one platform. So, there should be no more complaints? […]
Empower your Team Without Being a Constant Snag
The exact quote from our customer that inspired this heading was: “There’s a delicate balance between holding team members accountable and coming across like a jerk.” This speaks volumes of the additional complexity that comes with Risk Management. You would think that the complexity lies within putting the correct method, the models, the way we […]
