Using Reqview to manage requirements of medical devices

On-line documentation covers a very broad panel of use and configuration topics. The documentation is very easy to read and understand and also very straightforward. The support via email or their support portal is very efficient and effective in solving our issues or helping with advanced topics.

Pros

We use Reqview to record specifications of our medical robotic devices, both for hardware requirements and software requirements, in the scope of the EN 62304, ISO 14971 and ISO 13485 standard of the medical device industry. We use Reqview to analyze risks and trace the mitigations up to specifications and test cases. We record and trace test cases specifications in Reqview using multiple document projects. Everything is stored as json files which allows us to store the source files in a GIT server. Reqview has very easy to use export features allowing us to export Reqview documents into EXCEL or DOCX files matching with our company formatting templates so they can be archived within the documentation folder of our medical devices for regulatory purposes. ReqView is a perfect tool to support and enforce our quality process.

Cons

When features are missing, we can ask the Reqview team and they show their roadmap and progress done with features we are interested in. We can vote for upcoming features as well.

A super effective tool for designers

As a company, we appreciate the look and feel of the ReqView software, that is very much accessible for people working in a creative technical environment. Installation and maintenance is simple and the cost is very reasonable. As responsible for the implementation I have received substantial support from the ReqView team. Quite some wishes have resulted in features in the software (linked object hoover-over preview f.e.). Needles to say that I feel taken serious by ReqViews development team and that I am grateful for this We are confident about its use in the future.

Pros

One of the main benefits of ReqView is that it focusses really on the content that I am interested in as a designer in a product development process. There is little administrative and procedural overhead (clutter) in the program as well as in the user interface. This enables to view/read information paragraphs-wise almost like in word processing software. Having all information linked is fantastic for traceability and relative new to us, solving a documentation issue that could not realistically be solved with simple Office SW like Excel, Word etc.. ReqView is so simple that my compete design team can manage it, which is a great benefit over alternatives. The learning curve is steep, but really short (excluding HTML-programming). A super feature is the export into Word or PDF resulting in a compact document in which all linkage is still functional! How happy would I be as a client receiving such project documentation! Fantastic! Besides, also digital signing now is an option, a future must have!

Cons

The HTML programming needed for custom reports is something that you need to master, but from that point it offers many nice options. The recent ReqView update includes a wizard helping in this, which enables to create simple reports in under 30 seconds. So actually part of this pain is eased. Procedural rules, the delegation of formal rights etc. is not part of the software. Though we benefit from this, I can imagine that stricter application (quality systems) could ask for such functionality. However, we don't miss that at the moment.

Review by Albert

Pros

The capability to make traceability between documents and projects in a very efficient way.

Cons

The most critical of the SW to me is the 'CNTRl+Z' command does not exist.

Reqview for large-scale medical device development

The overall experience is very good. It solves what it does very well, and has a very good focus.

Pros

It allows implementation across a large team. Its very easy to use and allows for collaboration over SVN. The floating license solution makes deployment pain-free. Syncronization to JIRA (and onwards to Enterprise Architect) is critical for us to allow full traceability from user needs, through requirements, specifications and (via JIRA) into implementation and test management. ReqView is also extremely stable and we have used it for projects spanning several years with no data loss or problems.

Cons

For very large projects with very many documents it can get hard to get the overview (a folder structure would be good). It would also be good to have notifications (ie when logging into the tool) if another user has left a comment for you (tagged a user in a comment)

Great Value for feature-rich requirements management tool - Phenomenal customer support

This tool is awesome. Small footprint, Feature-rich, scalable, and easy to use! Definitely recommend for the value.

Pros

I liked the ease of use and the ease of integration and deployment: Use: 1. The scale was familiar enough from other tools to get running quickly. Secondly, the documentation, and adaptability for scaling, quickly aided in meeting more needs. 3. Customer support was timely and punctual in all the engagements, from licensing to questions on features, to clarifications. Deployment: 1. The native tools and web applications make this so easily scalable. 2. There was no dependency of a third party service or cloud was extremely helpful. (like having to maintain a server side cloud with IT and all that comes with it) 3. The storage structure of json files enable great configuration management through various means like SVN or git!

Cons

Having various "views" of each document within a project would be wonderful - i.e a b-directional trace view for analysis, vs. a publication & authoring view to only provide what is needed for a document/template. Integration with Azure DevOps (ADO) would be nice, however there are current workarounds with CSV imports/exports. I also want to be able to utilize a bit more integration with other MBSE tools, such as Capella. This is not as straightforward even with the provided documentation on ReqIF imports.