Hi All, In this week lecture Dr.Simon discussed Project Proposal (Initiating), which is the first document in a design control. Let us talk about How to prepare a successful project proposal for desig...

Hi All, As Dr.Simon mentioned in project management plan you have other things not in the DDP for example: Project Charter Scope Management Plan Communications Plan Quality Plan Risk Management Plan L...

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...

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...

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...

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 probl...

Hi All, recently the FDA approved the First Digital Pill in US, Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was tak...

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 mus...

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 ...

Hi All, As Dr.Simon mentioned about classification in EU is based on risk, Higher risk = higher classification, and Essential Requirements Checklist helps determine classification. In the US, the FDA ...

Hi All, As Dr.Simon mentioned about Tech file: It is a Comprehensive collection of information and documents, Contains Details everything about a medical device, Less complex for MDD Class I and 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 revi...

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 effor...

I did some research on marketing strategy, adding to the discussion, there are seven Ps for marketing: product, price, promotion, place, participation, positioning and people. People: To be successful...

As we have learned from Dr.Simon MDD1 (Medical Device Development 1) on WEEK 4 about combination product: Definition of Combination Product Primary mode of action = the single mode of action of a com...