I agree with previous comments about Correction being the short-term solution and Corrective action, on the other hand, is a long-term solution. Correction is taken to rectify a known nonconformance and Corrective Action is taken to prevent recurrence of said nonconformance.

I would like to illustrate this with simple examples of these 2 related…[Read more]

Thanks for the article and info @alexandrabuga. I agree that it is logical. And it would make things simpler. Other than the points from @kak33 comment, in comparison with ISO 13485, FDA 21 CFR Part 820 QSR is the law for medical device companies manufacturing and selling products for the US market. So I don’t think QSR would be replaced…[Read more]

I agree with previous comments about internal audits and would like to sum up and expand the pros and cons for this type of audits.
PROS
1. It helps compare your practices and processes against proposed prodecures and make corrections
2. It reduces the risks/chances of frauds
3. It ensures that accounting staff keep records up to date and are…[Read more]

I believe the above comments are solutions from the business/company admin side. To answer Fady’s question from the employee perspective, I believe the best way to communicate to management that additional resources are needed is to speak up management have to deal with constant budget cuts. A better management would have some plans for this but…[Read more]

Thank you for an interesting question with a lot of different views. In this unforeseeable situation, it’s difficult to say “to kill” or “not to kill”, it’s a case by case basis. And if it is “to kill”, I agree with some of you that when the market is not lucrative and supportive, the project is not fully “killed” but maybe hold off till a later…[Read more]

I agree with previous posts about funding being the key driving force to support change and innovation. I would like to add in the timing factor and market condition.
A lot of time, a deadline is a strong driving force to find the best and most effective way to execute tasks. Change/innovations can thrive in the right market condition.Innovation…[Read more]

There are three primary types of obsolescence: technical obsolescence (new technology surpasses the existing technology), functional obsolescence (when a technology can no longer be fixed//upgraded due to parts or software compatibility) and planned obsolescence (a business strategy used to increase sales).
Others have mentioned about the lengthy…[Read more]

I would like to add that it would be very costly to re-validate everything. Imagine there is mass production. This “critical machine” might have produced thousands of products if not more.
I agree with most of you about the decision to re-evaluate depends on the investigation of what went wrong. Some machines break down after a certain amount of…[Read more]

Hi, I agree with most of you about the fact that the device needs to be validated again once it’s moved because you don’t know what could have changed during the process.But depends on the condition, you may not need to do the full validation from scratch. I want to add an FDA reference to this (posted in the other thread as well about…[Read more]

Some critical-process standards include a requirement for re-validation at “defined intervals”, and to require that those “intervals shall be justified”. (Language of ISO 11135-1, EtO Sterilization.)
It is common in the US device industry to regard the outer limit for 11135 re-validation as three years, with a maximum interval of one year between…[Read more]

I agree with @srg36 that the way to master the skill is a lot of practice and experience. I would like to add reading to that list. I took Technical Writing as an undergraduate course, I was good but not essential. Nobody was really in my field then and the teacher tried to generalized all students so they could only provide the structure but not…[Read more]

I have never worked in the industry. With my very limited related experience, I think the best set up of QMS depends on the size and function of the company.If the company is very small, it’s ineffective to have such a big quality management system. For example, as @gp232 have mentioned about the QA department consisting of 2 people, as long as it…[Read more]

I think it’s always good to validate. I agree with @bb254 about engineers being trained per the SOP’s of the company and validating equipment. I think every employee, not just engineers should be made aware and trained in the validation process. To answer @tn58 original question about how to understand the validation process, I found flowcharts…[Read more]

I disagree with @srg36 and agree with @alexandrabuga about the need to update revision number. I think it’s needed to have all the docs updated once a revision is made. I also agree that it’s a lot of work and sometimes tedious to chase these related docs. An automated updating system can be a huge help. I found this Medical Device Document…[Read more]

I agree with opinions stated above. I believe the major challenge facing medical device regulators as well as manufacturer comes down to differentiating between combination devices that are primarily devices and those that are medicinal. This will even get harders with the adoption of new technologies such as bioelectronics because they could both…[Read more]

I would add on to the list of various devices being classification differently between the US and EU with needle destruction devices. These are not considered medical devices in Europe but they are class III in the United States. In Europe, these devices go through electrical safety and electromagnetic compatibility and compliance to the European…[Read more]

My answer is maybe not. Other than the lecture video, I have limited area about this topic so I did a search on it and found some interesting information. From the lecture, various reasons you guys have mentioned and various articles you guys have pointed out I would say that it’s easier to get approval in EU than in the US. However I came across…[Read more]

I agree with @alexandrabuga and @bb254 about the importance of Participation. I want to further emphasize the importance of participation, especially now in this era, participation is required to keep up with the market and maintain brand relevancy. Thanks to social media and social networks, brands and companies can get feedback on where they…[Read more]

I agree with you guys about the facts that there is no specific “good number” in the number of centers, multi-center clinical trials (MCCT) are expensive, there are a lot of aspects involving in MCCT. There is an article named “A guide to organizing a multicenter clinical trial.” on PubMed that showed a strategy tackling MCCT. Like many have…[Read more]

I am not working in the industry but my related field is vestibular rehabilitation. Currently, the focus of the field is toward automated systems and incorporating VR into physical rehabilitation. On the software side, the devices are made so that it relies on as little on human/physicians input as possible. Deep learning/AI are introduced to make…[Read more]