MDR
Conformité Européene
What does CE stand for?
Stakeholders that are directly affected by or influencing a project.
Who are primary stakeholders?
What is primary prevention?
This mark indicates that a medical device meets
the legal safety and performance requirements.
What is CE marking?
What a Magnetomyogram (MMG) measures.
What is signals in the muscle?
This is the highest risk classification for a medical device.
What is level III?
Regulatory agencies (FDA, EMA) tend to be this type of stakeholder.
What are secondary stakeholders?
Disease can be classified into these two groups.
What is infection and non-infectious?
Manufacturers of medical devices from higher risk classes must have their product assessed by a so-called "_____ ____". If the product complies, the manufacturer receives a CE certificate
What is notified body?
The fault is on this person/group if a medical device isn’t used in accordance with its intended use.
Who is the user?
This body defines the purpose of the medical device.
Who is the legal manufacturer?
Name one key stakeholder in the design process of biomedical engineering solutions.
Who is the clinician, the patient, regulatory bodies, etc ...?
This term refers to the number of new cases of disease present in a population in a given time period.
What is morbidity?
The use of information technology (IT) and telecommunications to monitor the health of individuals in their homes and to help ensure that appropriate action is taken.
What is health at home?
This theorem states that the sampling frequency of an analog-to-digital converter must be greater than the maximum frequency of the input signal.
What is the Nyquist theorem?
Method through which it is demonstrates through objective evidence that the outputs meet the inputs.
What is verification?
The tree types are Collaboration, Regulation, and Market Access.
What are stakeholder interactions?
Model used to determine where to place emphasis on the cause of a health problem.
What is the epidemiological triangle?
The SMART requirements.
What is specific, measurable, achievable, relevant, time-bound?
Of laparoscopy, amputation, and open surgery, this is the most invasive.
What is amputation?
Refers to the process of confirming that a medical device meets its intended use.
What is validation?
The FDA or something
The Roman Empire contributed greatly to public healthcare with this invention.
What are aqueducts?
The two primary approaches to identifying problems in the field of Biomedical Engineering.
What is technology looking for a problem and a problem looking for technology?
This QALY value means one year in perfect health.