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

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 cl...

Hi srg36, I think implantable orthopedic medical devices is the most highly regulated medical devices in the market. As we learned form the validation...

An engineering change order (ECO) is a documentation packet that outlines the proposed change, lists the product parts that would be affected. ECOs ar...

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 desi...

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 ...

Adding to the discussion, from my academic experience, for the documentation for any test done for a medical device,in general the risk management fil...

The Standard Operating Procedures (SOP) as SOPs are often used to demonstrate compliance with the regulation or operational practices and to document ...

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 c...

ECOs are used to make modifications to components, assemblies, associated documentation and other types of product information.The main reason for ECO...

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 beginni...