Different risk analysis methods like FMECA,FMEA includes (FMEA – PFMEA, Design FMEA – DFMEA), Root Cause Analysis (RCA),RCM (Reliability Centered Maintenance), and Risk and control self assessment (RCSA).
For example: FMEA Failure mode and effects analysis.
Benefits:
– FMEA is a procedure for determining where processes, products or designs are…[Read more]

CAPA is required under 21CFR820.100 It requires manufacturers of medical devices to have clearly documented procedures for corrective and preventive action. CAPA is important to continuous improvement processes. CAPA can help to lower the cost of quality because of it ability to capture quality issues early in production, thus helping to reduce…[Read more]

I thing the biggest advantage for internal audit, it gives you a chance to verify that your CAPA have been completed effectively and on time or not!. Also, the ability to identify non-compliance thing in the product and provide recommendations on ways to make improvements. Look at internal auditing not only as a regulatory compliance check, but…[Read more]

GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances errors or problems from a medical device for example. GMP is also sometimes referred to as “cGMP”. the “c” stands for “current,” reminding manufacturers that they must employ technologies and systems which are up-to-date in order to…[Read more]

Budget cuts doesn’t affect the cost estimation of the project. However it does affect the scope or quality of the project. A good project manager needs to resist that pressure and make sure that any cuts in project spending are done consciously with full knowledge of whatever impact those changes might have.

In the closing phase closing phase process, all documents of the project both in terms of device delivery, and project management delivery must be completed. Project actual results are reported and documented, project contracts are closed, and lessons learned documents are produced.
Final project reports include final documentation for…[Read more]

I think all the factors listed are very important for a project, and I think the most important thing is to Develop clearly defined plans with assigned responsibilities. For each task in thee project must be identified in your data management plan, and identify the skills needed to perform the task. Also, I think a successful data management plan…[Read more]

Actually all the factors listed above are a very important tools for a successful product manager, but I think its very important for the product manager to Stay informed about industry and market data, because better pricing and better service starts with better information. So the product manager should collect detailed data about your customers…[Read more]

Interpersonal skills is very important in negotiation. I believe a good negotiator should have some qualifications- for example:
– Preparation and planning skill.
– knowledge of the subject matter being negotiated.
– Ability to think clearly and rapidly under pressure and uncertainty.
– Ability to express thoughts verbally.
– Listening skill.
-…[Read more]

Introduction stage of a product life cycle, its a very important stage in the product life cycle, because the product manager should focus on marketing,advertising, pricing , distribution, and promotion to sell the product. In the introduction stage limited competition, if the product is truly original or the product is better than any other…[Read more]

The FDA recalled GE MRI in 2015.
Reason for Recall: Some MRI units may have been modified by service personnel or by equipment users to disable the Magnet Rundown Unit (MRU).
The MRU is one method used to shut off the magnetic field of the MRI in case of an emergency, such as when a metal (ferrous) object is brought into the magnetic field. In…[Read more]

Product development phase is the most important role in the product life cycle. As Dr. Simon mentioned, in the development phase you start to do:
Market Research, Design Control, Design Transfer, Approval, and IQ OQ & PQ. Because of the design control in the development phase, and design control is not only the right thing to do but also its very…[Read more]

First of all you need to think about the reason for any change, also if the change is essential or no?. If the change will add improvement to the project or or improvement for the device ?
To evaluate a change request, you need to find the answer for the following questions:
Is there a work-around, or is this change necessary for the overall…[Read more]

In monitoring and controlling phase of the project management lifecycle ensures that the project performance is monitored and adjustments to the project schedule are made as needed. According to PMBOK, in the monitoring and controlling processes accomplish three things:
– Track, review, and regulate the progress and performance of the project
-…[Read more]

Scheduling utilizes a combination of work breakdown structure and project information, these include:
tasks, key tasks, project types, location, project characteristics,WBS, and time and staffing standards.
As a project manager you need to plan for the unexpected things!.Things happen during executing the project, so as the project is being…[Read more]

I think validation is the most important process in a design control. As a project manager you need to know what is validation mean and how you validate a product. You need to make sure the device you have created is working in the human body and achieved the required goals. Validation is not only the right thing to do, but also its required by…[Read more]

When it comes to a timeline change in a project, this will causing delay in the project. If you are a project manager, you need to create accurate project timeline, that will help you reach your goals as planned. A Gantt chart timeline need to be followed in the project.
In project management you need to focus on:
The list of tasks to be…[Read more]