RAC Exam Prep - EU MDD/AIMDD & MDR Study Aid with Complete Solutions
11 views 0 purchase
Course
RAC
Institution
RAC
RAC Exam Prep - EU MDD/AIMDD & MDR Study Aid with Complete SolutionsRAC Exam Prep - EU MDD/AIMDD & MDR Study Aid with Complete SolutionsRAC Exam Prep - EU MDD/AIMDD & MDR Study Aid with Complete SolutionsRAC Exam Prep - EU MDD/AIMDD & MDR Study Aid with Complete Solutions
Similar but more detailed...
Which entity affixes it's identification number near the CE Mark? - ANSWER-
Notified Body, if involved in the conformity assessment
Un-classified devices not requiring CE mark - ANSWER-Custom-made,
Investigational, Compassionate/Orphan
All ----- contributing to the intended purpose must be considered - ANSWER-
Modes of action
,Define transient use - ANSWER-less than 60 minutes
Define short-term use - ANSWER-between 60 minutes and 30 days
What are the entities that make up the "economic operators"? - ANSWER-
manufacturers, Authorised Reps, importers, and distributors
When is a PMCF study mandatory? (MDD) - ANSWER-When CE marking is
based solely on clinical data from equivalent devices
A material is considered to have a biological effect if it actively and
intentionally ---- - ANSWER-induces, alters, or prevents a response from
tissues that is mediated by specific reactions at a molecular level
refers to a material's degradation within the body and metabolic elimination
of the resulting degradation products from the body - ANSWER-Absorption
Combination devices are most often classified as - ANSWER-Class III
, MEDDEV 2.4/1^7 is a guidance for - ANSWER-Classification under MDD
Standalone software is considered what type of device - ANSWER-Active
Software that drives a device or influences its use automatically falls in to
which classification? - ANSWER-That of the device
A clinical evaluation is required for - - ANSWER-every device, Class I through
III under all directives
If the literature shows new or other risks what may need to be updated? -
ANSWER-risk management plan
What is not required if a manufacturer can collect clinical evidence from
literature? - ANSWER-Clinical investigation
If a manufacturer and an NB cannot agree on the classification who is
consulted for a solution? - ANSWER-Competent Authority
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller NursingTutor1. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $14.99. You're not tied to anything after your purchase.