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 perform a routine procedure,…   Read more»

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 detailed and…   Read more»

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in many design review meetings in my company, and I would like to comment to djr32 that although it may seem outdated to have a scribe for a design review…   Read more»

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 whether or not to proceed with the…   Read more»

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 implanted in…   Read more»

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 manufacture all of…   Read more»

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 checked during…   Read more»

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 another beneficial aspect of doing thorough…   Read more»

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 packaging, the tests that are performed are usually very standardized,…   Read more»

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 well. From my…   Read more»

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 time on coming up…   Read more»

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 portfolio,…   Read more»

I personally think the matrix organization is most effective for running projects. It may seem a bit complicated at first, especially for someone who is currently working in a functional or project based organization, and people may think that the…   Read more»

I am unable to post the link to the article I referenced, but the website is MDDI (Medical Device and Diagnostic Industry), article title is Medical Device Quality Planning.

The quality plan is a very essential document, because it outlines the procedures/methods you intend to follow in the project to ensure that the product you develop meets all quality standards of your company and regulations of the governing body….   Read more»

I work within a matrix organization, but as Dr. Simon mentioned in his lecture about his experience with a previous company, I would label it as a weak matrix organization. The reason I would call it a weak organization is…   Read more»

I do not have any experience with clinical trials, but I think you raise a very important issue. Does over-regulation lead to a decrease in innovation? I believe that it definitely does, and there is a very delicate balance between…   Read more»

In addition to the points mentioned above, from my experience a very critical step in the project initiation phase is to lock down the scope of the project. In my company I believe that one of our biggest struggles is…   Read more»

I would like to add to the discussion by talking about my experience with 510k submissions. It definitely is possible for companies to embellish characteristics of an implant or testing results to claim equivalency to a predicate device. We had…   Read more»

I do not personally have experience with getting combination devices approved in the EU, but I did some research on this topic and I found an interesting article explaining that the EMA is considering developing a new guideline on quality…   Read more»