As Dr.Simon mentioned, if you failed to plan so you planning to fail. Planning phase is very important in any Medical Device project. Its important to identify critical interfaces in your project, resources you need, milestones you need to achieve…   Read more»

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 (QSR) a quality system regulation for medical device for…   Read more»

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, or it is a class III…   Read more»

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 medical device meets the user requirements and the…   Read more»

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, assemblies, associated documentation and other types of product information. A…   Read more»

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 contain some basic documents: PDF, DDP, DID…   Read more»

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 submitted to the FDA according to FDA 21…   Read more»

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 medical electrical device evaluated according to standard…   Read more»

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 think SOPs is not required in the research role…   Read more»

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 which loosing time and money. In project-based…   Read more»

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 might want to research other methods better suited to their own operations. For…   Read more»

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 collect information from sources…   Read more»

For me I prefer Matrix Organizations. In matrix organizations all the departments work closely together and communicate with each other frequently to solve issues. The specialized information exchange allows managers to respond quickly to the needs of clients and the…   Read more»

Tech File is easier, but DHF more useful. DHF : A compilation of records that contain the history of the design, such as validations, verification, qualifications, environmental testing, project plans, risk management activities, meeting minutes,design reviews etc. Often this will…   Read more»

In my opinion DHF is a living document (as we have learned) and must updated regularly. Your DHF should be a collection of the objective evidence that demonstrates you’re following 820.30. and every document in the DHF must be updated…   Read more»

I think the best strategy to take when a Validation or Verification report have failed to achieve the expected results is to think about the Requirements you need for your design, because common problems in the verification “story” come from…   Read more»

for any PM in any industry should have some skills like communication skills, leadership, team management, risk management, and planning skills. In the medical device industry the project managers must have a particular skill set in order to be able…   Read more»

Zoll LifeVest is a Class III , FDA requires PMA submission, for example implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators, and endosseous implants. This device also is used to help sustain life, which means high risk, so…   Read more»

It is easier to get devices approved in the EU than FDA: 1- FDA approval always requires a full clinical trial or trials, whereas the CE Mark in EU can be obtained through a clinical evaluation,a review of published data…   Read more»

Adding to the discussion, the advantages of multi-center trials are numerous:clear results which are more convincing and whose acceptance is higher, . However, multi-center trials require strong efforts for quality assurance concerning admission, treatment and follow-up, thus a highly developed…   Read more»