From my experience the tracking of medical devices in the post market surveliance often comes consumer feedback itself, we have a team that dedicates themselves to addressing potential issues. The address concerns with the use of the device and often times, from my experience, its a user error, the instructions within labeling were misinterpreted…[Read more]

I had that happen to me when I was working in the consumer sector, I was reforming out of a ester that is now discontinued, it was believed that it was going to be a very simple reform of a popular tanning lotion, we make a batch of the tanning lotion then put it on stability, and it was believed that we were going to have passing results, since…[Read more]

Based on the information give, since the material has been in the development phase for a decade, the potential of the material should by now be known or at least have a pretty good idea on what it could do with a possible set of pro’s and cons. One major decisive factor is the potential market the material has or in other words how it can effect…[Read more]

Hi All,

I can definitely agree that a budget cut will effect the project, thus area that may have been clear may have to be reanalyze to take into consideration the budget limitation. This aspect is very important for the project manager to maximize the budget fund to ensure that key areas within the project are not hindered by this limitation.…[Read more]

In my opinion an SOP, should be created to ensure repeatability of a process/ procedure. That being said it should be implemented when they are finalizing the product. Such an example would be if we create a new surgical stapler,we would want to be able to test the claims/standards of the stapler and its repeatable usage, which an SOP would be…[Read more]

Hi All,

Engineering change orders are an interesting and important topic. I am currently working on a few change orders for the CAPA that I am working on. I am basically updating test methods for laboratory testing equipment , which are meeting current manufacturing standards. Essentially the ECO is used to address the change of an SOP or…[Read more]

I completely agree with the comments above, the fitbit is not a medical device and it should not be liable to provide ” accurate measurements” if you think about the concept of properly monitoring heart beats, the fitbit is a type of device that ” one size fits all” so that alone should be a slight indication that it’s placement on the wrist will…[Read more]

There already is a ” right to try” legislation with regards to having experimental drugs given upon the request of a terminally ill patient. I attached two articles below that explains…[Read more]

Great topic, as a the comment above me mentioned the FDA acts as a ” Gate keeper”/ filter for consumers and ensures that good quality products reach the market that have a minimal amount of impact on their well being. That being said, decreasing the FDA’s ability to monitor and filter out potential harmful goods could be devastating to our market…[Read more]

As Fady mentioned, essentially they have the same content, but the major difference is that the technical file has the current standards/specifications for the device and it does not take into consideration the design history. In my opinion, the DHF is an important tool in a validation/verification aspect, but this extra content may not be useful…[Read more]

In my opinion I would consider the DHF to be a living document. Often times in a products life span there could be changes in materials/processes and its good to look back at historical data in order to compare data sets. I know in my experience I have looked at historical data and compared different aspects of validation/verification of equipment…[Read more]

By definition, verification evaulates whether or not product or system complies with a requirement, specification, or regulation, while validation assures that the product meets the needs of the customer or in other words meets the operational needs of the user. I know within my experience, if a new process is replacing a standard one, a…[Read more]

I definitely agree with the posts above, the design control in particular that should be reevaluated should be the verification/validation aspect of this product. Risk analysis should be conducted as well. It is important to take into consideration is that it is a homeopathic product and is not as regulated as intensely as an OTC or a prescription…[Read more]

I agree with the comments above validation and verification should be approached at the close stage of the project. The idea is that you want to ensure that it meets the user needs through validation and you look at the design inputs/outputs through verification. I slightly disagree with one of the comments above, Quality Assurance from my…[Read more]

From my experience with Validation and Verification, I have particularly worked on lab equipment or instruments used to make or inspect a particular medical device in a manufacturing settings. With respect to equipment/instruments the company may have a template on how establish or approach your validation/verification. With the design of a…[Read more]

Ideally they should have a set system or a method to prevent these tragedies. My only exposure with respect Regulatory agencies within the European union and the US market is within a cosmetic aspect. I know for sure that there are specific chemicals that are banned or they are gradually being removed from the European market but are still…[Read more]

Although, I personally have never dealt with the European Union regulations for medical devices, from what I understand medical devices adhere to three directives: the active implantable medical device directive, medical device directive and in vitro diagnostic device directive. But as Fady mentioned earlier, notified bodies review devices, but do…[Read more]

Hi all,

As everyone mentioned above, it is easier to have devices approved in the EU, the main reason is that the regulatory aspect is not as strict when compared to the US regulatory agencies. In addition, the FDA was created based on tragedies and incidents that compromised peoples health and lives, thus adjusting its regulation while the…[Read more]

Artificial meat is an interesting concept, but with respect to long terms effects, would the increase in chemical intake effect/compromise our bodies? I believe that when the technology enhances and we acquire the ability to develop artificial organs, then this would be considered a class III medical device, since they have the potential to…[Read more]