No GMP will certainly result in a cheaper process and the product will also sell at a lower price. Nevertheless, GMPs is what establish your credibility to other organizations, to your customers. It proves that you are a viable supplier of the product and that your product is being consistently produced with quality, integrity and there will be…[Read more]

Product failure can be described in two categories; product risk & business risk. Product failure is not a fun thing to deal with and a lot of companies deal with it in different ways. Some companies have a non-conformance tracking system where quality notifications are initiated when a non-conformance occurs. Sometimes it can be parts that were…[Read more]

Interpersonal skills and business skills vary from one company to another specially in medical device fields where it’s not so easy to do everything yourself with all the ISO & FDA regulations. I’ve seen and heard about companies that take care of the sales portion for many medical devices. Those guys have the engineering background as well as…[Read more]

In my opinion, there is really no scrap of a project due to patent issues or money. There is always a priority change in which project management plays a huge role depending on the business needs.

I’ve seen some products being put on hold due to complexity levels in which some of the features were just added to a functioning instrument. This…[Read more]

During post-launch product management, it is very important to keep track of the product’s quality performance by interacting with the customers and keep track of it. This way you are ensuring that customers are not only satisfied with the new product but they are also getting all the features and benefits promised as marketed during promotions…[Read more]

Hi gh56, I do not experience on this area yet. Nevertheless, I believe that it is difficult to pinpoint any role as the most important role for a product manager since they are equally important and they all relate to marketing. As a product manager, you own a particular product line and you serve as a critical link between the product and the market.

If the machine severely failed in manufacturing, the first step is to investigate the root cause of the failure. Once the root cause has been found, a correction must be performed. If the failure can have a product risk then a CAPA might need to be initiated and this might include process changes therefor this might require revalidation.

Hi all,
After my undergraduate, I have to say that I really did not have any background knowledge of how the industry worked in regards to medical devices. I learned a lot from part 1 and part 2 MDD. From the classification of the devices to design controls and FDA & EU regulations. The understanding of design process led me to set an area in…[Read more]

Hi all,
Even though I still do not have experience in Validation, but I think that a type of Validation could also be Revalidation.
Revalidation means repeating the original validation effort or any part of it, and includes investigative review of existing performance data. This approach is essential to maintain the validated status of the plant,…[Read more]

HI gh56,

I think that under the FDA the QSR embraces the same “umbrella” approach to the CGMP regulation that was the underpinning of the original CGMP regulation. Because the regulation must apply to so many different types of devices, the regulation does not prescribe in detail how a manufacturer must produce a specific device. Rather, the…[Read more]

For the Vascular Graft Weaving Line – weaving the polyethylene fabric tubes that make up a vascular graft… I believe that the IQ, OQ and PQ will be as following:

IQ- The machine weaving the polyethylene fabric has been installed under proper electrical configuration according to its installation SOP. The environmental area and conditions in w…[Read more]

Hi all,
A DHR is a key deliverable from design controls and it is a checklist that is used during manufacturing of the device. The DHR, is created during design controls but it is not used until manufacturing of the device. Therefore, during manufacturing the DHR defines how a device or a lot of devices should be produced to meet specs. For…[Read more]

Hi all,
I have not had any experience with any ECO since I still do not have experience in the medical device industry. But to my understanding. some examples in which ECO is needed could be when a modification will have an effect:
– On the product- Maybe a correction of a design error that doesn’t become evident until testing and modeling, or…[Read more]

It is interesting to learn that Section 522 of the Federal Food, Drug and Cosmetic Act gives the FDA the authority to require a manufacturer to conduct post-market surveillance of a class II or class III device when the device meets the following criteria:
(1)its failure would be reasonably likely to have serious adverse health…[Read more]

Design verification tests whether each design output meets design input requirements. Therefore, individual design verification test aims to prove that each design output complies with each specification created from the DID. Design validation tests if the design conforms to user needs and intended use under specific operating conditions and risk…[Read more]

I believe that the DHF should be a living document that reflects the current state of the device. Keeping track of the changes (SOP’S, material, packaging, labeling..etc) and updating the DHF gives an appropriate and up-to-date information to anyone who needs to refer back to it for any given reason. As Chris mentioned, if the DHF is consistent,…[Read more]