For me I prefer Matrix Organizations. In matrix organizations all the departments work closely together and communicate with each other frequently to ...

Tech File is easier, but DHF more useful. DHF : A compilation of records that contain the history of the design, such as validations, verification, qu...

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 th...

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 Requireme...

for any PM in any industry should have some skills like communication skills, leadership, team management, risk management, and planning skills. In th...

Zoll LifeVest is a Class III , FDA requires PMA submission, for example implantable pacemaker, pulse generators, HIV diagnostic tests, automated exter...

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 ca...

Adding to the discussion, the advantages of multi-center trials are numerous:clear results which are more convincing and whose acceptance is higher, ....

I did some research on marketing strategy, adding to the discussion, there are seven Ps for marketing: product, price, promotion, place, participation...

As we have learned from Dr.Simon MDD1 (Medical Device Development 1) on WEEK 4 about combination product: Definition of Combination Product Primary m...