Regulatory Affairs for Medical Device Clinical Trials in Asia Pacific

Wong, Jack; Kaiyu, Raymond Tong

doi:10.1201/b14081-15

Cited by 28 publications

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“…For example if the reference is the use of BSI standards, it will be titled as BS [standard number]-[number of parts]:[year]. A full list of national standards bodies is included in Appendix C1.ISO 13485 is an international standard on Quality Management System (QMS) for all medical devices explicitly for regulatory purposes(Goodall & Bos, 2013). ISO 13485:2003 is a standalone document and is the current international standard being used worldwide except for EU countries.…”

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Design and implementation of CE medical decision model on research medical devices

Tan¹

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John Gerard for his invaluable guidance, patience and trust in my abilities to embark on this interesting work in this research area where very few technical details but more on regulatory affairs and requirements related to medical devices. I would like to thank my ex-working supervisor Dr Foo Jong Yong Abdiel from Ngee Ann Polytechnic for his vast experience in the quality assurance and regulatory compliance associated with medical devices and also his thoughtfulness in encouraging me to take up the studies while working. I am also very grateful and thankful to my excolleagues from Ngee Ann Polytechnic for their experience and kind guidance in the preparation of this thesis. I would like to thank my family members, Mr Tan Swee Chye and Mr Tan Xin Quan Jake, and especially my mother, Mdm Lee Bee Hwa, who really trusted in my capabilities on taking up a masters course to further my research interest. I would like to also thank my fiancée-to-be, Miss Ratna Yanti Ng Xue Ting, who is always there for me, having faith and trust in my capabilities and also encourage me when I am at my lowest point in writing this thesis. I am very grateful to Nanyang Technological University (NTU) for its research facility, without which this work would not have been possible. Lastly, I would like to thank my friends for their essential support.

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“…ISO 13485:2003 is mostly used in achieving the regulatory requirements when performing the registration for medical devices. A well-implemented ISO 13485 QMS will enhance the reliability and consistency of the processes used by the company(Goodall & Bos, 2013). It will also assist in the waste and defect reduction in the production phase.…”

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Design and implementation of CE medical decision model on research medical devices

Tan¹

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ICH Q10 Quality Systems

Wigman

Ooi

2017

ICH Quality Guidelines

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Automotive and medical: can we learn from each other?

Kramer¹

2011

J Software Evolu Process

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In this paper, we present an analysis of the new standard ISO 26262 for the automotive industry. We compare this standard to existing regulations of another safety-critical domain, that is, the medical device industry. As can be expected, a large number of activities coincide, because they simply correspond to common best practices that can also be found, for example, in ISO/IEC 15504. However, some interesting differences can be observed both in philosophy and in wording that make cross-domain communication complicated. This paper is intended to encourage the exchange of experiences and methods between the two domains that are driven by the same concern, that is, the user's safety. We point out the most striking similarities and differences and translate from one domain to the other.

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Regulatory Affairs for Medical Device Clinical Trials in Asia Pacific

Cited by 28 publications

References 0 publications

Design and implementation of CE medical decision model on research medical devices

Design and implementation of CE medical decision model on research medical devices

ICH Q10 Quality Systems

Automotive and medical: can we learn from each other?

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