Conformify eQMS for Medical Devices
yayıncı: Conformify GmbH
An ISO 13485 compliant eQMS made specifically for manufacturers of medical devices.
Power your medical device to market through the Conformify eQMS software!
Most quality management software only manages your quality data. But can it tell you how to write a Clinical Evaluation? Or provide all your quality procedures, checklists, forms and templates? Conformify software does.
Most QMS software out there is designed to manage your quality data. This means that it can maybe trace your requirements to your risks and test cases, or provide you with customer complaint forms and workflow, but you still need to create your own Standard Operating Procedures (SOPs), templates, etc. to be compliant.
Most QMS software only really deals with ISO 13485 clauses of the quality system and does not support other aspects such as developing a clinical evaluation, reporting to authorities, post market surveillance requirements, etc. Conformify supports all these and more.
Has everything you need
When going into the market with a medical device, you don’t just need to worry about a QMS. You also need to worry about other regulations that you are subject to, such as periodic reporting, post-market surveillance, which could include post-market clinical trials. Conformify can support all of this.
Other QMS software promises to be customizable, but in the end you can only really change some forms or some minor aspects of workflows. This may not be enough for you. Also, they may charge you excessive amounts to make this customization.
Works out of the box
Many QMS software requires a large amount of configuration before you can even start using it, which can be expensive and time consuming. Conformify works out of the box. Simply upload the SOPs and documents you need, and you are off!
Doesn’t require excessive training
Many QMS software on the market have a steep learning curve and so these companies provides days of expensive training before you can get up and running. Conformify requires a small amount of training and then the rest is self-explanatory. The wizards take care of the rest.
To understand the magic of Conformify, it might be best to work through an example.
Imagine you are an organization that has a medical device cleared for a specific market and you want to make a change to it. Let’s step through how Conformify will support you from A to Z.
Step 1. First, go to the set of business activities that you are allowed to launch and press 'I want to make a change to a cleared device'
Step 2. Next, work through the wizard to build a project. These wizards guide step-by-step and are customizable to your organization.
Step 3. Each step that requires a resource will ask you to assign one.
Step 4. Now that the work packages and resources are added, Conformify automatically creates the first task of the work package and assigns it to the correct resource.
Step 5. This resource receives this new task in their inbox. By clicking on the task, they get a complete explanation of what is required of them directly from the SOP and are automatically presented with the relevant forms and templates for them to download and fill out.
Step 6. They can simply upload their document when they are finished, and the next set of tasks are automatically triggered.
Step 7. As the project progresses, each resource automatically receives tasks in their inbox as needed by the organization's SOPs.
Skipping through to the end of the project…
Step 62. Now you can go to the device documentation dashboard and filter for ‘FDA 510(k) file’ and see all the documents that should be compiled together for a 510(k) submission. Or you can filter for your MDR technical file. Or your Risk Management file.... Or any file your company has defined.