I agree with those who said that SOPs are not needed for the research phase of a project. It is important to remember that SOPs are very specific, detailed instructions that tell how you how to perfor...

In the first simulation this week, we are requesting changes to documents in the Quality System hierarchy. The hierarchy laid out in this simulation is the Quality Manual on the top, followed by Quali...

Most of the posts above state that the SOP should be a very detailed document, and I agree with that as well, but I also like the comments made about being concise. There is a difference between being...

I have sat in on and been an active participant in many design review meetings in my company, and I would like to comment to djr32 that although it may seem outdated to have a scribe for a design revi...

From my experience there is not necessarily a risk/benefit ratio, but rather the company performs an analysis where they weigh all the risks and compare them to the benefits and make a decision whethe...

If I were a PM running a risk management meeting, I would first create a timeline of events with my team from the time the device is shipped out of the manufacturing facility till the time it is impla...

In medical device projects that I have worked on and am working on, one of our most important external stakeholders are our suppliers. We do not do any in house manufacturing, so we rely on vendors to...

For those of you who work in industry, I am curious whether your company uses ECOs or another similar form of documentation to execute a change to a product. My company uses the CCF (Change Control Fo...

The purpose of an ECO is to provide a framework for making a change to a product once it is already released to the market. Going through the ECO process makes sure that you check everything that was ...

I agree with the above posts regarding the strategies used in post market surveillance (PMS) as well as the benefits obtained from doing PMS. I would like to add to the conversation by describing anot...

Packaging development is a very important part of a medical device project, and in my company, we have engineers who are dedicated to package development. For packaging, and especially sterile packagi...

I agree that choosing the right project team is a very important part of the project initiation phase. However, in almost any team, there will probably be a few team members who do not get along very ...

I agree that it is important to have a good plan of how to handle testing failures when doing your V&V, but I like the points that @gh56, @merzkrashed, and @Sanam brought up, about spending more t...

Hello everyone, In the topic this week we spent a lot of time learning about the DSD document, a very important document in the DHF. However, in my company, we do not fill out a DSD. Instead, we fill ...

The school of thought that says that the DHF is sealed at the end of Design Transfer is most appealing to me, and that is the school of thought that my company follows. We have quite a large product p...