50 Questions
What is the purpose of a quality management system (QMS) in the context of medical device regulation?
To ensure consistent meeting of customer requirements and satisfaction
Which product falls under Class IIb as per the classification of medical devices in Europe?
Pacemakers
What is the purpose of a Declaration of Conformity in the context of medical device regulation?
To declare conformity with the essential requirements and standards
What does MDR Annex IX primarily focus on?
Definition of regulatory strategy and conformity assessment procedures
In the context of medical device regulation in Europe, what is the role of a Notified Body?
To assess and approve technical documentation for medical devices
What is one of the main aspects of the quality management system according to DIN EN ISO 13485?
Documentation of design evolution
In the context of the regulation of artificial organs in Europe, what is required for customer related requirements (URS)?
Controlled purchasing with verification of purchased articles and supplier
According to the Medical Device Regulation (MDR) 2017/745, what is included in the technical documentation?
Documentation of design and development file for each product
What is one of the aspects covered in the declaration of conformity for artificial organs in Europe?
Product definition & classification
What is a requirement for the verification and validation process according to the European Medical Device Regulation MDR 2017/745?
Documentation of design reviews and decision
What is the purpose of the Test according to the given text?
To reveal the ink flow of the pen
In the context of the Quality Management System DIN EN ISO 13485, what is the main aspect mentioned in the given text?
Plan and document development
What does DRS stand for in the given text?
Design Requirement Specification
According to the given text, what does URS refer to?
Customer related requirements
What is the main difference between MDR and MDD in terms of conformity assessment?
MDR requires all medical products to be recertified, while MDD does not have this requirement.
What is the validation test mentioned in the text?
Test reveals ink flow is 107 +/- 4 mg/km
Which chapter of the MDR 2017/745 focuses on the classification and conformity of medical devices?
Chapter 5: Classification & Conformity
What is the purpose of Annex III in the MDR 2017/745?
Post-market surveillance
What action must a manufacturer take before placing a medical product on the market according to the MDR?
Submit a declaration of conformity to a Notified Body
What is the main difference between MDR and MPDG in relation to medical device regulation?
MDR replaces MPDG and introduces a transition period, while MPDG does not have a transition period.
Which authority is responsible for the surveillance of medical products on the market in Germany?
Bundesinstitut für Arzneimittel und Medizinprodukte
How many Notified Bodies are currently certified for Medical Device Regulation (MDR) in Europe?
36
What is the role of ZLG (Zentralstelle der Länder für Gesundheitsschutz) in Germany?
Certification and monitoring of Notified Bodies
Which annex of the Medical Device Regulation (MDR) primarily focuses on clinical investigation?
Annex XV
In the context of medical device regulation, what does the term 'Custom-made devices' refer to?
Devices made specifically for individual patients
What is the main focus of the Medical Device Regulation (MDR) in Europe?
Regulating medical devices and accessories for human use
What does the Medical Device Regulation (MDR) replace?
Medical Device Directive (MDD)
Which of the following is NOT covered by the Medical Device Regulation (MDR) in Europe?
Medication
What is the transition period for compliance with the Medical Device Regulation (MDR) in Europe?
Till 05/2024
Which entities need to be recertified according to the Medical Device Regulation (MDR)?
Both medical products and notified bodies
What must be included in the documented quality policy according to the text?
Quality objectives and documented quality policy
What is a required documentation for the Quality Management System (QMS) as per the text?
Documents and Records of all processes needed to maintain and improve the QMS
In the context of medical device regulation, which chapter discusses the Definition of Quality Police and commitment?
Chapter 5
What is a requirement for the documented quality policy according to the text?
Quality objectives and documented quality policy
Which type of documents must be included in the documentation of the QMS according to the text?
Documents and records of all processes needed to maintain and improve the QMS
What is a requirement for the Quality Management System (QMS) documentation as per the text?
Documents and Records of all required processes
Which chapter in the text discusses Documented quality policy and quality objectives?
Chapter 4
What should be included in the Documentation of the QMS according to the text?
Quality manual and list of all processes needed to maintain and improve the QMS
Which documents are required for maintaining and improving the Quality Management System (QMS) as per the text?
Quality manual and records of all processes needed to maintain and improve the QMS
Which chapter discusses Documents and Records of all required processes according to the text?
Chapter 4
What must be included in the documentation of the Quality Management System (QMS) according to DIN EN ISO 13485?
Records of all processes needed to maintain and improve the QMS
Which chapter of DIN EN ISO 13485 focuses on the definition of Quality Policy and commitment?
Chapter 5
What is the main aspect covered in Chapter 4 of the Quality Management System DIN EN ISO 13485?
Documentation of the QMS
What does DIN EN ISO 13485 primarily focus on?
Requirements for quality management systems in the medical device industry
In the context of medical device regulation, what is the purpose of Chapter 5 of DIN EN ISO 13485?
Outlining the documentation needed for maintaining and improving the QMS
Which standard governs the requirements for regulatory purposes in Europe as per the given text?
DIN EN ISO 13485:2016
What is NOT a part of the documentation required for the Quality Management System (QMS) according to DIN EN ISO 13485?
Clinical trial reports
According to DIN EN ISO 13485, what is one of the main aspects that must be included in the QMS documentation?
Records of all processes needed to maintain and improve the QMS
What must be included in the documented quality policy and quality objectives as per the given text?
Records of customer complaints
What does Chapter 5 of DIN EN ISO 13485 primarily focus on?
Documentation required for maintaining and improving the QMS
This quiz covers the regulatory requirements for medical devices in Europe, including classification rules, conformity assessment procedures, certificates, clinical evaluation, and other related topics.
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