Regulation based product definition for an impedance pneumography measuring system
Kellberg, Linda (2014)
2014
Sähkötekniikan koulutusohjelma
Tieto- ja sähkötekniikan tiedekunta - Faculty of Computing and Electrical Engineering
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Hyväksymispäivämäärä
2014-03-05
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:tty-201402281102
https://urn.fi/URN:NBN:fi:tty-201402281102
Tiivistelmä
Producing medical devices for commercial use within the European Union (EU) is a highly regulated process. The related regulation mainly consists of three medical device directives developed by the European Commission: the Medical Device Directive (MDD) 93/42/EEC, directive 90/385/EEC concerning active implantable medical devices, and directive 98/79/EC covering devices for In Vitro examination of specimen, as well as the related guidance documents i.e MEDDEVs. Additionally, medical device manufacturers are encouraged to utilize directive documents crafted and published by specialized organizations and harmonized European standards to ensure and facilitate the fulfilment of the objectives set by the directives.
The Impedance Pneumography (IP) measuring system is qualified as a medical device and has to be designed and manufactured according to the requirements set out in the MDD. Accordingly, the manufacturer has to design and implement the related processes, and establish adequate documentation on the development of the system beginning from the very definition of the product. The definition should include the intended purpose of the system, its qualification accordingly, and classification according to the classification rules presented in the MDD. The manufacturer also has to identify the other EU regulations and/or directives applicable to the product and any relevant harmonized standards accordingly, as they both increase the amount of individual requirements directed to the product and help to create frames for the design specifications.
The objective of this Master of Science Thesis is to create an initial product definition for the IP measuring system in accordance with the MDD. The definition will cover the intended purpose of the product, its qualification accordingly and its classification according to the MDD classfication rules. The Thesis will also define other EU directives and the harmonized standards applicable to the design and development of the system. Furthermore, the Thesis will provide an initial assessment of the feasibility of the product and an initial requirements definition for the solution found most desirable by the becoming manufacturer.
The Impedance Pneumography (IP) measuring system is qualified as a medical device and has to be designed and manufactured according to the requirements set out in the MDD. Accordingly, the manufacturer has to design and implement the related processes, and establish adequate documentation on the development of the system beginning from the very definition of the product. The definition should include the intended purpose of the system, its qualification accordingly, and classification according to the classification rules presented in the MDD. The manufacturer also has to identify the other EU regulations and/or directives applicable to the product and any relevant harmonized standards accordingly, as they both increase the amount of individual requirements directed to the product and help to create frames for the design specifications.
The objective of this Master of Science Thesis is to create an initial product definition for the IP measuring system in accordance with the MDD. The definition will cover the intended purpose of the product, its qualification accordingly and its classification according to the MDD classfication rules. The Thesis will also define other EU directives and the harmonized standards applicable to the design and development of the system. Furthermore, the Thesis will provide an initial assessment of the feasibility of the product and an initial requirements definition for the solution found most desirable by the becoming manufacturer.