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.

Perfectly-sized requirements management tool with all the most relevant features; responsive team

Pros

It has apparently been created by people who understand requirements management. It checks almost all boxes that are important to me. It pretty much takes the good parts of DOORS, and leaves out the bad ones. The ReqView team are very responsive, and attentive to the desires of their users. I have great expectations for future releases.

Cons

There are currently three different implementations (native app, web app, Chrome extension), all of which are missing a bit of functionality that's important to me, even though other implementations have it.

Initial impressions of a new ReqView user.

Pros

All I really wanted to do was get on with the task of defining my project requirements, and the thought of facing a steep learning curve, on any new requirements suite, was not something I wanted to go through. However, ReqView presented me with no such 'learning curve' hurdle, and as soon as it was installed I found I could get on with defining my project requirements knowing that the formatting of the 'deliverable' document could be refined later on in the process. This is exactly the sort of requirements platform I was looking for... and ReqView delivered it to me.

Cons

The general editing of tables could perhaps be enhanced. I found that the look and layout of them within the ReqView environment could be improved, and some of the editing features did not work exactly as intended. For example there is a confirmed bug associated with the table popup in the editor dialog, where the popup buttons or dropdowns don't work sometimes, such as when trying to edit rows. However the ReqView support team did provide a workaround which allowed me to get my editing done.

'Right-sized' between capability versus ease of use and maintenance.

An easy-to-implement and -maintain requirements management system. It doesn't try and be the answer to everything we have ever needed in our development process, which usually leads to overly complicated software which drives your system, rather than the other way around. ReqView fills just the slot we need it to.

Pros

We are a small development group that does not have the bandwidth to justify dedicated resources to learn and customize a complex tool. We have periods of heavy activity followed by months of not touching the tool, so ease of use was at the top of our list of priorities. Additionally, being in the medical device field, we already have many systems in place and do not want to disrupt what is already running smoothly. ReqView is very specific about what it is trying to accomplish, and does it well. It is easy to learn (we have only needed the online documentation) and the pricing makes it a no-brainer to start playing with. The product is definitely a work in progress, with new features being added on a regular basis. A couple of them have been as a result of requests I made personally, so you can't get better responsiveness than that! Rather than trying to do everything, ReqView provides straightforward import and export to standard MS Office software. For version control, we treat it like source code in a Subversion database, but it can be used on a shared drive. Updates are easy and automatic. It's not SAAS, which our IT department would have nixed for security reasons, plus there's not the delay involved with remote servers.

Cons

Customization of outputs to fit the needs of the project documentation is usually a bear, and ReqView is no exception. We had the same issue (except worse!) with previous RM software. Someone who is well-versed in HTML and CSS might find this easy, and there is copious documentation available at w3schools.com, but I admit to spending much more time to generate a half dozen or so output scripts than the rest of the first project in its entirety! Now they are done, so it's no longer an issue for the future, but it was a steep curve. Obviously, if you only need formats closer to those provided, your experience will be easier.