I did my undergraduate degree at NJIT in ME, and I thought that I got a decent amount of exposure to technical writing, especially in the form of lab reports. Although it may not be the same as design control documents in industry, you still need to use the same clear and concise writing style mentioned by neb2. It is not an easy skill to learn,…[Read more]

I agree with the posts above that the inputs for the DID should be gotten directly from the end user or customer. In my company the marketing department is responsible for gathering VOC (voice of customer) inputs and using this feedback to compile the DID. The engineers are then responsible for translating the inputs into design specifications.…[Read more]

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, and they are mostly used in manufacturing. Research is the opposite of routine, so SOPs for research would not make sense. I…[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 concise vs. detailed and redundant. I would also like to add to this conversation by discussing the correlation between how detailed an…[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in many design review meetings in my company, and I would like to comment to djr32 that although it may seem outdated to have a scribe for a design review meeting, we still have scribes for all of our design review meetings to document everything that was discussed. I personally think this is more…[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 project. Often they get a clinician’s input when making this determination as well. However, an output of this analysis…[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 the patient and even after that. Then we would work through the timeline, identifying any hazards that may occur at each step. This process…[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 our product. Since they are such an important stakeholder, it is critical to set expectations with your suppliers and maintain a…[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 the design of the product to ensure that the changes you are making will not negatively impact the safety of the product. Sometimes…[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 PMS. Gathering information regarding product failures is the most important step of initiating a root cause…[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, and the packaging engineer does not have to define new tests each time we are…[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 experience I have found that the best way to handle situations like this is to get to know your team members on more of a personal…[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 with a reasonable and appropriate value for the acceptance criteria to reduce the risk of having failures during V&V. This definitely…[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, so if we had to update every DHF every time we updated any SOP or our design control procedures, I think we would be spending almost all of…[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 idea of being accountable to 2 people is stressful. However, if it is run correctly, I believe it can…[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. 21 CFR 820 Subpart B states, “Each manufacturer shall establish a quality plan which defines the…[Read more]