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 organization the whole team is focused on the team’s goals.
I prefer to work for a M…[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 example, if the product or process changes can impact many areas…[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 such as:
information from vigilance, records referring to non-serious incidents and data on any undesirable side…[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 organization. The ability to contribute valuable information before decisions are…[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 include all revisions of a procedure, drawings, etc. also Clinical…[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 as you go in your design. If you’re lined up for an inspection, you could get into trouble with FDA if it’…[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 poor requirements.
Also, Plan It Before You Do It, always plan right before starting verification pro…[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 to efficiently control medical device product development. The competencies needed for this role…[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 definitely will be Class III.
And, also, according to FDA definition for mobile…[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 for existing equivalent devices.
2- The documentation required from investigators is much less efficient for FDA submissions…[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 coordinating center is needed.
Also, multi-center…[Read more]

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 in business, you must develop the habit of thinking in terms of exactly who is going to carry out each task and responsibility. In many cases, it’s…[Read more]

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 combination product that provides the most important therapeutic action of the combination product.
Includes two or more separate products packaged…[Read more]

Mobile medical apps are mobile apps that meet the definition of a “device” which are intended either:

1- To be used as an accessory to a regulated medical device; or
2- To transform a mobile platform into a regulated medical device.
So, since your app will transform a mobile platform into a regulated medical device and will be used as a hea…[Read more]

Further, according to FDA, a “general wellness product” falls into one of two categories, and either:

Has (1) an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of cer…[Read more]