Activity | Luisa Gutierrez | Medical Device Courses

Luisa Gutierrez replied to the topic "The change from ALARP to AFAP" – 5 years, 11 months ago

Risk cannot always be eliminated by design solutions. This is why medical devices use protective measures (i.e., – alarms) and inform users of residual risks (i.e., – warnings and contraindications in an Instructions For Use (IFU). The “ALARP” concept has… Read more»
Luisa Gutierrez replied to the topic "Manage Risk" – 5 years, 11 months ago

I agree with the comments above. The acceptance leads to a high severity of risk due to the company not any additional steps to deal with the risk. As Dr. Simon has mentioned, sometimes it is cheaper for the company… Read more»
Luisa Gutierrez replied to the topic "Risk Management Mistakes" – 5 years, 11 months ago

This is an interesting discussion. The main one that I believe is overlooked is the lifecycle process of risk management. Most companies, as expressed by article, only work with this portion during product development. But is it important to also… Read more»
Luisa Gutierrez replied to the topic "Combination Product Phase I clinical Studies" – 5 years, 11 months ago

Good discussion topic. I found this interesting link that provides a helpful visual on page 3 to understand where Phase I Clinical Studies would occur. As per the source, it shows that as part of the design validation, the clinical… Read more»
Luisa Gutierrez replied to the topic "Design Transfer" – 5 years, 11 months ago

The benefits to outsourcing the design transfer into manufacturing process are leveraging multidisciplinary expertise have breakthrough ideas from other industries and technologies and be able to expand without needing to maintain the technology in-house. Expand internal engineering capabilities helps to… Read more»
Luisa Gutierrez replied to the topic "When is validation is not required?" – 5 years, 11 months ago

In general, validation is an important part of getting a product to market because it verifies that the user needs are met. Even though it may take up to a few years to complete, it can improve the launch success… Read more»
Luisa Gutierrez replied to the topic "What are Design Controls?" – 5 years, 11 months ago

I agree with the responses so far. One of the aspects that I think design controls help to bring out in the product development process is risk management. This is a way to take the policies, procedures, and practices to… Read more»
Luisa Gutierrez replied to the topic "Design input sources" – 5 years, 11 months ago

I agree with what has been said so far. The design input is the document that provides the basic requirements of the product. It takes the input from different sources like marketing, sales, direct team, customers in order to obtain… Read more»
Luisa Gutierrez replied to the topic "Design Controls for Legacy Combination Products" – 5 years, 11 months ago

Fady, That is an interesting point to bring up. With combination products, if I understand correctly, the company must identify first the necessary center for the primary use of the product. Once it is designated into CDER, CBER, or CDRH… Read more»
Luisa Gutierrez posted a new topic "Non-Conformity" – 5 years, 11 months ago

In this week’s lecture, Dr. Simon discussed about nonconforming product and how action must be taken to make sure the DMR requirements are met. In addition, any rework must be completed before releasing the product into market. Does anyone have… Read more»
Luisa Gutierrez posted a new topic "Standard Operating Procedures (SOP's)" – 5 years, 11 months ago

During this week’s lecture, Dr. Simon discussed about SOP’s and how they are part of the integrated quality system. He also described how they are important/required to be part of any GMP process. Do you think that SOP’s should be… Read more»
Luisa Gutierrez replied to the topic career path in the forum Clinical Trials for Medical Devices 7 years, 11 months ago

The clinical research path I know would not be something for me. But I do see it to be a good learning experience and provide a great base knowledge in regards to clinical studies and how the whole documentation process is handled per clinical trial participant. Also, it helps to understand at firsthand how the patients work with the device and…[Read more]
Luisa Gutierrez replied to the topic Clinical Study Location/cost vs. results in the forum Clinical Trials for Medical Devices 7 years, 11 months ago

I agree with the statement above that the clinical trials may be conducted depending on partially where the disease may be more prominent but the secondary is also the cost. This cost can be whether the company is directly managing the different sites or acts as a sponsor and has a CRO that performs the entire process. In addition, depending on…[Read more]
Luisa Gutierrez replied to the topic Consent and predicted outcome in the forum Clinical Trials for Medical Devices 7 years, 11 months ago

Both of the cases provided above are great representation of a clinical trial going wrong. Companies before reaching the clinical trial stage, they make sure the pre-clinical trials are successful and the device is effective. Also, the company makes sure to allocate enough budget just in case the unexpected results occur and is able to compensate…[Read more]
Luisa Gutierrez replied to the topic Management Responsibility in the forum Quality Systems Management 7 years, 12 months ago

That is an interesting point to bring up. Within my current company, I have seen how teams are not allowed bring in more individuals even though the workload has increased. And it is unfortunate because it puts more burden on the current employee. To solve this current issue, the company tends to hire more contractors rather than employees through…[Read more]
Luisa Gutierrez replied to the topic correction vs corrective action in the forum Quality Systems Management 8 years ago

From my experience, I am actually working on a project that currently deals with both. Due to regulation change in Asia on how the packaging is labeled, we were able to create the new product to reflect the change. However, with the old product in stock that does not have that change, in the system it shows that I can be shipped but in reality the…[Read more]
Luisa Gutierrez started the topic Non-Conformity in the forum Quality Systems Management 8 years ago

In this week’s lecture, Dr. Simon discussed about nonconforming product and how action must be taken to make sure the DMR requirements are met. In addition, any rework must be completed before releasing the product into market.
Does anyone have any experience or examples of nonconforming product and personally seeing the flow into a CAPA? Also, w…[Read more]
Luisa Gutierrez replied to the topic Discussion Topic: When Quality Systems change in the middle of a project in the forum Quality Systems Management 8 years ago

I agree that is a change in the quality system occurs, the projects would have to be evaluated and see if the change will completely change the parameters of the project or allow them to be grandfathered in. If a change would need to be created between multiple project, it is imperative that the company creates a strategy that provides different…[Read more]
Luisa Gutierrez replied to the topic Discussion Topic: Vagueness of GMP's in the forum Quality Systems Management 8 years ago

With the way the GMP requirements are set up, it seems that it is trying to make any start-up companies fail. But as mentioned above, the GMP have general requirements to allow any style of company whether it is in the health industry or even food industry to mold and create an efficient process. Also, the GMP requirements was created based on…[Read more]
Luisa Gutierrez replied to the topic No GMPs in the forum Quality Systems Management 8 years ago

That is great input to this discussion so far. To add to the idea, the GMP is definitely required to also ensure that the product being sold is consistent. If the documentation used to make the product didn’t provide the necessary instructions and details, it may cause the production working to make a device with drastically different d…[Read more]
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