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hg93 replied to the topic Organization Type vs. Effectiveness in the forum Organizational Development in Device Companies 8 years, 4 months ago
This is a good discussion topic related to the organizational structure. According to PMBOK, organizational structure is defined as an enterprise environmental factor which affects the availability of resources and influences how the projects are conducted.
As discussed by Dr. Simon that there is the disadvantage that there is limited knowledge…[Read more] -
hg93 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
One of the points for avoiding risk I would like to add to manage risk is Exploitation.
Exploitation: To exploit the risk. The techniques mentioned above are great when they have a negative impact in the project but what if the risk has the positive impact?
For example, the risk that the new washing machines are so popular that we don’t have e…[Read more]
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hg93 started the topic Risk Management – Identification in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
Risk management is the process of analyzing, identifying and responding to risk factors throughout the course of the project. Managing risks early on in the project is the best way to avoid project catastrophes. Continuously applying the right risk management tools early on and all the way through the life of the project will ensure that risks…[Read more]
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hg93 replied to the topic Factors Contributing to Risk Values in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
Risk index number = impact of risk event x probability of occurrence
The impact of the risk event is commonly assessed on a scale of 1 to 5, where 1 and 5 represent the minimum and maximum possible impact of an occurrence of a risk (usually in terms of financial losses).
The probability of occurrence is assessed on a scale from 1 to 5, where 1…[Read more] -
hg93 replied to the topic Combination Product Phase I clinical Studies in the forum Introduction to Design Controls 8 years, 4 months ago
Design plans are just a plan. In fact, this is stated in both Clause 7.3.1 of the ISO Standards, and in Section 21 CFR 820.30b of the FDA QSR.Design control for 1st phase include the following 16 tasks:
Identification of the regulatory pathway based upon the device risk classification and applicable harmonized standards.
Development of a risk…[Read more]
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hg93 replied to the topic Combination Product Phase I clinical Studies in the forum Introduction to Design Controls 8 years, 4 months ago
Design plans are just a plan. In fact, this is stated in both Clause 7.3.1 of the ISO Standards, and in Section 21 CFR 820.30b of the FDA QSR.Design control for 1st phase include the following 16 tasks:
Identification of the regulatory pathway based upon the device risk classification and applicable harmonized standards.
Development of a risk…[Read more]
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hg93 replied to the topic Combination Product Phase I clinical Studies in the forum Introduction to Design Controls 8 years, 4 months ago
Design plans are just a plan. You can and should change that plan. In fact, this is stated in both Clause 7.3.1 of the ISO Standards, and in Section 21 CFR 820.30b of the FDA QSR. You can make your plan as detailed as you need to, but I recommend starting simple and adding detail. Your first version of a design plan should include the following 16…[Read more]
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hg93 started the topic Design Transfer in the forum Introduction to Design Controls 8 years, 4 months ago
As discussed closing phase is one of the most critical aspects of a project and can sometimes be looked at as a project of its own. Dr. Simon this week discussed the basis of the Design Transfer, an important part of the closing. It includes finishing off the Design Controls and moving the device from prototype form to production ready. It takes…[Read more]
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hg93 started the topic Design Transfer in the forum Introduction to Design Controls 8 years, 4 months ago
As discussed closing phase is one of the most critical aspects of a project and can sometimes be looked at as a project of its own. Dr. Simon this week discussed the basis of the Design Transfer, an important part of the closing. It includes finishing off the Design Controls and moving the device from prototype form to production ready. It…[Read more]
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hg93 started the topic Design Review Meetings in the forum Introduction to Design Controls 8 years, 4 months ago
As mentioned in the lecture, design review meetings happen at the end of each stage in the project. They are critical because they facilitate communication between the design team, management, and the customer. The design team provides information about the status of the project to the manager and customer and also receives feedback regarding the…[Read more]
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hg93 replied to the topic Design Verification & Validation in the forum Introduction to Design Controls 8 years, 5 months ago
Great discussion so far!
Verification and validation are two critical elements of product development. One informs the elements of a product’s design, while the other looks at those design elements in the hands of users. Although often used synonymously, these alliterative terms sit on opposite sides of the product development life c…[Read more]
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hg93 started the topic Important Part of DDP in the forum Introduction to Design Controls 8 years, 5 months ago
Design Development Plan (DDP) contains:
*final scope statement
*scope management plan
*quality management plan
*communications management plan
*team member list/responsibilitiesCommunication management plan is the most important part of the DDP because communication management plan contains information on how to contact people and the rules to…[Read more]
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hg93 started the topic What are Design Controls? in the forum Introduction to Design Controls 8 years, 5 months ago
“Design Controls” is a FDA term and defined in FDA 21 CFR 820.30. Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and correcting errors through an iterative process of development.
Open up the discussion about Design Con…[Read more]
