title: Limited Awareness of the Essences of Certification or Compliance Markings on Medical Devices.
abstract: Medical devices have been long used for odiagnostic, therapeutic or rehabilitation purposes. Currently, they can range from a low-cost portable device that is often used for personal health monitoring to high-end sophisticated equipment that can only be operated by trained professionals. Depending on the functional purposes, there are different certification or compliance markings on the device when it is sold. One common certification marking is the Conformité Européenne affixation but this has a range of certification mark numbering for a variety of functional purposes. While the regulators and medical device manufacturers understand the associated significance and clinical implications, these may not be apparent to the professionals (using or maintaining the device) and the general public. With portable healthcare devices and mobile applications gaining popularity, better awareness of certification marking will be needed. Particularly, there are differences in the allowed functional purposes and the associated cost derivations of devices with a seemingly similar nature. A preferred approach such as an easy-to-understand notation next to any certification marking on a device can aid in differentiation without the need to digest mountainous regulatory details.
authors.affiliation: Electronic and Computer Engineering Division, School of Engineering, Ngee Ann Polytechnic, 535 Clementi Road, Singapore, 599489, Singapore. faj2@np.edu.sg.
authors.forename: Jong Yong Abdiel
authors.initials: JYA
authors.lastname: Foo
authors.affiliation: Electronic and Computer Engineering Division, School of Engineering, Ngee Ann Polytechnic, 535 Clementi Road, Singapore, 599489, Singapore.
authors.forename: Xin Ji Alan
authors.initials: XJA
authors.lastname: Tan
mesh_terms: D001364:Awareness; D002568:Certification / Q000331:legislation & jurisprudence / Q000592:standards / Q000706:statistics & numerical data / Q000639:trends; D003365:Costs and Cost Analysis; D004869:Equipment Safety / Q000639:trends; D004864:Equipment and Supplies / Q000191:economics / Q000941:ethics / Q000592:standards*; D006282:Health Personnel / Q000523:psychology; D006801:Humans
keywords: Ethical practices; Patient safety; Product development; Quality assurance; Regulatory requirements