I would like to point out that post market surveillance can also be conducted on clinical studies. The importance of Post Market Clinical Follow Up (PMCF) studies is to try to identify and investigate any enduring risks that are associated…   Read more»

Yes, SOPs should be used in research phase. If you are looking to produce a new product to market or making changes to current products in your product line, SOPs should be strictly followed. During the research phase, chances are…   Read more»

The company I currently work for generates ECOs to make specific changes to products or manufacturing processes. Our ECOs are generated in a Product Management System, we currently use Agile but there are others such as OTIS or ADAPTIV. Basically,…   Read more»

In agreement that acceptance criteria needs to be re-evaluated. Before that, a deviation should be opened to address the failure of a validation and why the deviation occurred and how it will be addressed. I would re-evaluate what additional testing…   Read more»

It depends what you are looking for. The DHF would be more useful all around for people in Quality, Regulatory, Supply Chain, and even Product Development. This is because this will provide more then enough information for all the departments…   Read more»

The DHF is a living document. Logically to me it doesn’t even make sense why it wouldn’t be. What is the point of documenting just the original process if you are going to open a 2nd DHF if the product…   Read more»

In the US, nonabsorbable sutures can be classified as Class II with moderate risk of injury. In addition, absorbable sutures can be classified as Class II. In EU it is considered Class IIb medium to high risk if it is…   Read more»

Absolutely. The revisions that have taken place under the Medical Device Directives are meant to be on par or if not more stringent then the US FDA. Notified bodies showing up unannounced and greater scrutiny, which wasn’t existent at this…   Read more»

I don’t believe there should be a defined limit of center or subjects because that should depend fully on what the study is. However, when choosing multi centers or shouldn’t be random centers that chosen just because they are close…   Read more»

At the medical device company I work at, our marketing team focuses on actively following the customers who continue to buy our products. They stay on top of any issues the customer has in terms of malfunctioning devices, questions, or…   Read more»

As an engineer that currently uses 3D printing, most 3D printing applications have been used toward manufacturing equipment and fixing parts as opposed to 3D printing actual devices. Most items I am 3D printing are used to help fix a…   Read more»

I believe when you move from one medical device company to another, as part of the application or on-boarding process they ask “Have you worked for a company in which you are legally non-competing or restricting you from applying”. It…   Read more»

This course was excellent in giving a high overview of how the medical device industry functions. The lectures were really informative and gave me a better understanding about departments that I work with directly. It also helped me weed out…   Read more»

Agree with this. Competition is always good to keep people motivated to bring their best each and everyday. However, if its taken to the point where one is stepping on someone else to move up or get a promotion, then…   Read more»

I work in an organization that is both Functional and a Matrix organization. We essentially use project managers within departments that lead the projects with a staff beneath them. Most of the project managers pertain to Engineering. There is definitely…   Read more»

A lot of companies and regulators such as BSI, put a lot of time and effort to ensure that the IFUs and graphic labels on the product match. I can see both sides why this is important and why this…   Read more»

It helps if a similar product is already approved in whatever country the company is trying to release their product. If it is a whole new product that is being brought to market most of the cost are going to…   Read more»

Point #4 – Risk Management is not a lifecycle process is one of the most common errors that occurs for most companies when they assess risk management. Risk management is done at the beginning stages of product development and theoretically…   Read more»

In agreement with this post. AQL levels for most companies are the guideline for identifying what the sample size should be depending on the risk. However, further analysis such as power level, significance level, confidence intervals, etc can be applied…   Read more»

Agree with this in terms of having an established amount of lots, units, and time for running the validation. If you are conducting a validation you would want to prove that a set amount of lots or units is sufficient…   Read more»