Exam (elaborations)
RAC Exam Prep - EU MDD/AIMDD & MDR 2023 with complete solution;(Study Aid - RAC)
- Course
- Institution
RAC Exam Prep - EU MDD/AIMDD & MDR 2023 with complete solution;(Study Aid - RAC)
[Show more]
Seller
Follow
Victorious23
Reviews received
Content preview
RAC Exam Prep - EU MDD/AIMDD & MDR 2023with complete solution;(Study Aid - RAC)
Similar but more detailed than the Essential Requirements - -General Safety
and Performance Requirements
-This ISO standard includes the most recent update to specific medical
device companies quality management system? - -13485:2016
-Which entity affixes it's identification number near the CE Mark? - -Notified
Body, if involved in the conformity assessment
-Un-classified devices not requiring CE mark - -Custom-made,
Investigational, Compassionate/Orphan
-All ----- contributing to the intended purpose must be considered - -Modes
of action
-Define transient use - -less than 60 minutes
-Define short-term use - -between 60 minutes and 30 days
-A material is considered to have a biological effect if it actively and
intentionally ---- - -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 - -
Absorption
-Combination devices are most often classified as - -Class III
-MEDDEV 2.4/1^7 is a guidance for - -Classification under MDD
-Standalone software is considered what type of device - -Active
-Software that drives a device or influences its use automatically falls in to
which classification? - -That of the device
-If a manufacturer and an NB cannot agree on the classification who is
consulted for a solution? - -Competent Authority
-How can a manufacturer appeal the CA's decision of a classification? - -in
the national courts
, -Define horizontal/Level I standards - -General Standards relevant to
all/wide range of product types
-define Semi-horizontal/level 2 standards - -requirements applicable to a
range of similar products (surgical instruments)
-Define vertical/level 3 standards - -apply to a single product type or narrow
range of products
-Define comparator device - -established device bearing a CE Mark that is
used as a reference in a clinical investigation NOT a predicate device like
FDA)
-What is the ISO for biocompatibility? - -ISO 10993
-IEC 60601 regards - - -electrical safety and electric magnetic disturbance
-The amount of a medical device's testing is/should be commensurate with -
- -it's potential RISK to human health
-Name the two forms of clinical data used in CE marking - -1. compilation of
relevant scientific literature currently available on the device's intended
purpose, techniques employed and critical evaluation of the compilation
2. results and conclusions of a specifically designed clinical investigation
-What is contained in Annex 1 of the MDD, AIMDD and MDR? - -Essential
Requirements (GSPRs in MDR)
-A clinical evaluation is required for - - -every device, Class I through III
under all directives
-If the literature shows new or other risks what may need to be updated? - -
risk management plan
-What is not required if a manufacturer can collect clinical evidence from
literature? - -Clinical investigation
-State of the art = - -current generally accepted technology and
performance output not to be confused with top-of-the-line.
-FSCA - -Field Safety Corrective Action
-ISO 14155 - -Clinical investigations of medical devices in human subjects
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 Victorious23. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $10.49. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
72964 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now