qmsWrapper believes in continuous growth, persistent improvement, and we are happy to announce the first major update/release for this year.
First – qmsWrapper has a new feature that is helping you to be just one click away from securing your important data to your place! Why? Because your data is always your own, it’s your right to have access any time you want or need.
Save all your data stored in qmsWrapper to your location
qmsWrapper is the perfect software invented by a team of developers that have experience with creating a Medical Device. Hence, we made sure to meet your needs, Medical Device creators. We are completely aware that there are a tremendous number of files uploaded on our storage. All necessary documentation for your FDA and CE submission, in order for your Medical Device to see the light of day.
Therefore, we are now giving you the option to download any folder you want, for any purpose you need. We may give you a hint: you might need it in case of an offsite audit or if you would like to have your local copy.
qmsWrapper believes in security, that's why we use AWS back up. We are applying Risk Assessment as well, preventing losing any data and, putting it on a minimum.
There are many worries while developing a Medical Device, but now one less. qmsWrapper wants you to feel safe while working.
Second – now export your new processes in PDF
The exported PDF can make your life a lot easier
In our previous release, we introduced you to our new enterprise-grade processing engine. Your business and QMS workflows, processes and procedures are now more effective, flexible and adaptable.
One of its functionalities is that your new processes and its flowcharts now can be exported as PDF. Why is that so awesome?
Your new flowcharts exported in Portable Document Format, or PDF for short as a consistent format can be viewed by anyone else as it is. Anyone viewing the document will see it exactly as it was intended to be.
Through flowchart, in a particular way you are creating your procedures, and when exported it literally can be used as your SOP. Your processes and procedures each include step-by-step instructions to help you to correctly perform a specific task. It all comes to that, having your SOP ready.
The third one – but not least important.
The Updated Risk Module
What does that actually mean? One of the qualities of qmsWrapper is that it’s always keeping up with the times, changes and new challenges.
qmsWrapper’s Risk Module supports advanced Risk-based design. It’s an updated version according to ISO 14971:2019. And it’s harmonized with new MDR requirements bringing a few changes in procedures that our upgraded software practically predicted.
Risk assessment of high-risk medical devices requires a method of a certain way of verification and validation. With qmsWrapper’s Risk Module, you are led through various steps that will help you see if your risk control actually reduces the risk.
Obtaining sufficient data and information for risk estimation can be difficult, resulting in uncertainty if the residual risk evaluation. It can, therefore, be practical for the manufacturer to focus on the verification effectiveness of risk control measures to establish a convincing residual risk evaluation.
Feel free to book a Live Demo with our experts and find out more about these new features. It will not take you more than 15-30 minutes. Have your questions ready and hit this button. They will gladly explain all that you would like to know to get your Medical Device straight to the market.