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0 Exakte Antworten 89 Text Antworten 46 Multiple Choice Antworten


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Which of the following products are medical devices?





prefilled syringe

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What is the difference between in vitro diagnostic and in vivo diagnostic?

In vitro diagnostic medical device is a device which is intended to be used for the examination of specimens derived from the human body. (Device working outside the body)

In vivo diagnostic medical devices can be used in or on the human or animal body (device working inside the body).

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Present and differentiate the fundamental elements of conformity assessment.

conformity assessment means the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled. (e.g. testing, calibraton, inspections, certification)

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Present the major steps and elements of the risk management process.

I: Risk evaluation

II: Risk control

III: Risk communication (documentation)

IV: Risk Review

Start with I again.

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List the elements of conformity assessment for medical devices.

1. Quality Management System

2. Risk Management System

3. Technical Documentation

4. EU Declaration of Conformity

5. CE-Marking

6. System of Post-Market Surveillance (PMS)

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Name the basic elements of the quality management system of a medical device manufacturer

Basic Elements:
- Quality Management
- Personnel
- Documentation
- Production
- Quality Control
- Complaints and Product Recalls
- Self Inspection/Audit

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What is the CE-mark?

The CE marking indicates the conformity of the product with health and safety standards.

The CE marking is affixed on products that will be placed on the EEA and Turkish market, whether they are manufactured in the EEA, in Turkey or in another country.

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What is the purpose of the quality management system?

Observance of all aspects of production activites to assure quality

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Differentiate the major characteristics of the standards ISO 9001 and ISO 13485.

ISO 9001:2015                                                        
> Stand-alone standard
> General requirements for a QM system
> Generically applicable   
> Risk based thinking for planning and realization of processes of the QM system

ISO 13485:2016
> Stand-alone standard, but based on ISO 9001 regarding general QM criteria
> Specific requirements of the QM systems for medical devices sector
> Only applicable in the sector of medical devices
> Application of risk management for the safety and performance of medical devices and with regard to the fulfillment of    regulatory requirements

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Summarize major content of documentation as needed for EN ISO 13485

- Document controls

- Quality policy & manuals

- Standard operating procedures

- Work instructions

- Forms

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Differences between S1 and S2?

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See picture

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Resources, facilities & equipment

Resources, fatalities & equipment

Rules, guidelines, procedures, protocols

Rules, guidelines, procecution, protocols


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Performance of study, study plan, conduct of study, final report

Performance of study, seat plan, conduct of study, final report

Computerized Systems

Computer-based System

Quality assurance, advice, audit, inspection, training

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Characterization test article, identification, quality test system, reference item

Characterization test article, identification, quantity test system, referral item

Documentation, SOP, raw data, final report, software, archives, retention of materials

Documentation, SOP, processed data, final report, software, archives, referral of materials

Personnel, qualified, special training, good scientific practice

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Name three Good Practice QMS and order them in occurrence in a project.

1. Good laboratory practice (GLP) for early stages of drug development
2. Pre-clinical studies
3. Good manufacturing practice (GMP) for the manufacturing of clinicla product throughout the drug production
4. Good clinical practice (GCP) for/during the clinical studies/trials

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1. Concerning Biotechnologies, for a bioanalytical device which parameters must be defined/characterized? Name at least 4 parameters.

  • Specificity

  • Sensitivity

  • Robustness

  • Simple handling

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2. Which is the most relevant analytical procedure for protein analysis? Please, describe the process and name two parameters that make protein analysis difficult?

- the procedure: Immunoassay

- the process: measures the presence or concentration of a macromolecule or a small molecule in a solution through the use of an antibody (usually) or an antigen (sometimes).

- the parameters that make protein analysis difficult: binding affinity of the antibody, structure of the protein, function of the protein. In addition the absorbance depends on the type of protein analyzed (different proteins have different amino acid sequences).

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4.b What is conformity assessment?

Conformity assessment is the process used to show that a product, service, or system meets specified requirements. These requirements are likely to be contained in an ISO standard.

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What is an in vitro diagnostic medical device (IVDMD)?

Directive 98/79/EC, Article 1, defines IVDMDs as follows: “in vitro diagnostic medical device”: any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

- concerning a physiological or pathological state,

- concerning a congenital abnormality,

- to determine the safety and compatibility with potential recipients,

- to monitor therapeutic measures.

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3. Name the current EU medical device regulation. How many classes for medical devices are defined within this regulation? Describe these classes.

ISO 13485

4 classes (I, IIa, IIb, III):
I. Lowest risk classification. Non-sterile and/or non-measuring function; No notified Body involvement.
IIa. Manufacturing systems audit
IIb. Manufacturing & product design audit (Technical File)
III. Highest risk classification. Manufacturing & Design Dossier audit   

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Directive 98/79/EC, Article 1, defines IVDMDs ... for the purpose of providing information on...

concerning a physiological or pathological state

concerning a congenital abnormality

determining the safety and compatibility with potential recipients

monitoring therapeutic measures

concerning the safety and congenital ability

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6. Please provide four examples of "key features" of the GMP Pharmaceutical Quality Management System.

Validation, Verification, Compliance, Recall, Quality Control

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7. The CTD, The Common Technical Specification is the regulatory required format for submission of data in drug development. What parts in drug development does the CTD address/ require the information to be provided?

Validation, Verification, Vendor Management, Quality Control

Change Control, Deviation Investigation, Quality Control, CAPA

Change Investigation, Deviation Control, Quality Management, PCR

Facilities/ Utilities/ Equipment, CAPA, PQR/ APR, Complaints

Recall, Destruction, Change Control, Incidence

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What is the CTD?

The Common Technical Document (CTD) is a set of specifications for a dossier for the registration of medicines. The CTD was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and adopted by the Therapeutic Goods Administration (TGA) in 2004.

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What is the organisation of the common technical document?

The Common Technical Document is organised into five modules. Module 1 is region specific. Modules 2, 3, 4, and 5 are intended to be common for all regions. Conformance with this guideline should ensure that these four modules are provided in a format acceptable to the regulatory authorities.

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5. What are the pertinent Quality Management Systems required in the production of medicinal products (drugs) with the intention to authorize the medicinal product (drug)? Please name three regulatory controlled Quality Management Systems and allocate the required QMS to the phase in medicinal product (drug) development.


Good Laboratory Practice (GLP) for early-stage drug development, the pre-clinical studies, Good Manufacturing Practice (GMP) for the manufacture of medicinal product throughout the medicinal product (drug) production, and Good Clinical Practice during the clinical trials. 

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What does DIR stand for?


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What does REG stand for?


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What does ICH stand for?

= international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (GMP/GLP/GCP/CTD)

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What does OECD stand for?

= The Organisation for Economic Cooperation and Development (GLP)