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Semester I Examinations 2010/2011
4HF2, 1APE1, 1APE2
Exam(s) B. Sc (Health and Safety Systems) Master of Applied Science (Enterprise Systems)
Module Code(s) IE447 Module(s) Regulatory Affairs and Case Studies
Paper No. 1 Repeat Paper External Examiner(s)
Dr. F. Dick
*Dr P. Donnellan Prof. P. McHugh
Answer any FOUR questions.
No. of Pages Cover + 1 page
College/Discipline Engineering & Informatics/Industrial Engineering Course Co- ordinator(s)
Ms. M. Kelly
Q1 a) The European Medical Device Directive (MDD) addresses safety issues for medical
devices sold in the European market. Explain how it achieves this task?
b) Explain the role of the US Food and Drugs Administration (FDA) in protecting public safety
for medical devices, and also explain how it carries out this important role form a regulatory
point of view for companies manufacturing medical devices in Europe for use in the US
Q 2 a) The design process in a medical device organisation is a critical step in assuring customer
safety through device quality. Explain how you would measure the quality of the design
process using ISO13485 Quality Systems Requirements for Medical Devices. (i.e. section
7.3 of the standard) (15 marks)
b) List five other key Procedures required by the ISO13485 Standard and explain their
importance from a regulatory point of view.
Q3 There is a high degree of similarity between environmental and safety management systems
e.g. ISO14001 and OHSAS18001. Explain the main requirements of these systems focusing
on the common requirements. In your answer show how you would approach the
development of an integrated system for EH&S management. (25 marks)
Q4 Write short explanatory notes on Three of the following topics: (8 1 /3 Marks each)
i) A Product Liability Prevention Programme ii) The importance of the Seveso II Directive iii) Risk Management e.g. as presented in the DVD Risk Maker Risk Taker or other
examples of your choice.
iv) The HACCP Process for food safety v) The most relevant sections of the Product Safety Regulations, 2004, for a producer
of consumer products in the EU?
Q5 The Machinery Regulations (S.I, 407 of 2008) came into effect on December 2009. Explain
the significance of this directive to:
a) A current manufacturer of machinery b) A company that does not manufacture machinery but who operates several machines
both old (Pre 1990) and new (Post 2009) in their Company.
In your answer you should define a machine, a manufacturer and the CE approval process.