Adding to the discussion, another pitfall in Gantt chart that if you have poorly defined CAPA time-frames. CAPA which means establishing a corrective and preventive action system, which is required in...

I think re-validation is required or not depends on the product. So, you need to ask some questions about your medical device, is it something like class I devices, like tongue depressor for example, ...

Hi srg36, I think implantable orthopedic medical devices is the most highly regulated medical devices in the market. As we learned form the validation process lecture, Validation is to ensure that the...

An engineering change order (ECO) is a documentation packet that outlines the proposed change, lists the product parts that would be affected. ECOs are used to make modifications to components, assemb...

According to what we have learned from this class,so far, As a PM, Can you share your Ideas about How run Risk Management meeting ? How to start the meeting ? what you need to focus on during the meet...

Hi All, This week Dr.Simon talked about Risk (Probability that some undesired consequence will occur) and How to manage the risk in a Risk management plan. Let us talk about the definition of Risk/Ben...

Dr.Simon mentioned (in Week 3) about DHF, Design History File is required by law in 21CRF820.3(e) – “a compilation of records which describes the design history of a device”. Also, the DHF should cont...

Its very important on the validation process to make sure that the output equal to the user needs!. Before your company start marketing for a medical device, a successful validation should be submitte...

Hi Everyone, SOPs are very important documents to build a strong quality system. Let us discuss How to write SOPs, what should be included to avoid FDA audit ? For example: I think Procedures is the...

Adding to the discussion, from my academic experience, for the documentation for any test done for a medical device,in general the risk management file which is done by QA department. For example, a m...

The Standard Operating Procedures (SOP) as SOPs are often used to demonstrate compliance with the regulation or operational practices and to document how tasks must be completed at any organization. I...

Hi All Last lecture Dr.Simon talked about Risk Management Plan. Let us discuss the Risk Management Plan topic. What's Risk Management Plan mean and where to start in Risk Management Plan, also what do...

From my experience, I worked for a project-base company before, project-base company is easy to work with, but sometimes sometimes closing a project can mean losing your job or wait for next project w...

ECOs are used to make modifications to components, assemblies, associated documentation and other types of product information.The main reason for ECO (for example) ,product improvements, or companies...

Adding to the discussion, also in EU the manufacturer is required to produce a PMS plan, specific to each of its products. This is key to the beginning of a successful.The plan must outline how to co...