100% satisfaction guarantee Immediately available after payment Both online and in PDF No strings attached
logo-home
RAC Exam Prep - EU MDD/AIMDD & MDR Study Aid with Complete Solutions $14.99   Add to cart

Exam (elaborations)

RAC Exam Prep - EU MDD/AIMDD & MDR Study Aid with Complete Solutions

 12 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...

[Show more]

Preview 3 out of 23  pages

  • September 29, 2024
  • 23
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers
  • RAC
  • RAC
avatar-seller
NursingTutor1
RAC Exam Prep - EU MDD/AIMDD

& MDR Study Aid with Complete

Solutions


Similar but more detailed than the Essential Requirements - ANSWER-

General Safety and Performance Requirements




This ISO standard includes the most recent update to specific medical device

companies quality management system? - ANSWER-13485:2016




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

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

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

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.

Can Stuvia be trusted?

4.6 stars on Google & Trustpilot (+1000 reviews)

72042 documents were sold in the last 30 days

Founded in 2010, the go-to place to buy study notes for 14 years now

Start selling
$14.99
  • (0)
  Add to cart