ISO 14971: Application of Risk Management to Medical Devices

Wong, Jack; Kaiyu, Raymond Tong

doi:10.1201/9780429504396-16

Cited by 2 publications

(5 citation statements)

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“…Every product that the company develops should be prepared with a well-established RM plan. The RM plan can be further developed into templates for the use on other similar products (Chan & Tong, 2013). The RM plan mainly refers to the risk acceptability criteria that are defined in the RM policy as shown in Figure 10.…”

Section: Risk Management Planmentioning

confidence: 99%

“…With a good understanding in the intended purpose of the developed product, this will form a basis in identifying any known and/or foreseeable dangers beforehand. Once the hazards have been clearly identified during the risk analysis stage, the severity and chances of occurrence in the harm level is required to be assessed and subsequently generating a score in the risk level of the identified hazard (Chan & Tong, 2013).…”

Section: Risk Analysis (Clause 4)mentioning

confidence: 99%

“…The emphasis on this clause is the information gathered after all the risk measures/controls in Step 3 has been carried out (Chan & Tong, 2013). The company should have a systematic process in retrieving information about the device during and after the production phase.…”

Section: Production and Post-production Information (Clause 9)mentioning

confidence: 99%

“…Full lifecycle of ISO 14971:2007 modelRisk Management PolicyThe management of a company should document the RM policy by taking into consideration of the appropriate and related worldwide, nationwide, regional or harmonized standards and regulation(Chan & Tong, 2013). The RM policy should include an explanation on determination of the risk acceptability and also a periodic review of the risk management activities.…”

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confidence: 99%

“…The similarity between the international standard and the European version is that the clauses or requirements stated in both standards remain exactly the same but the difference is that there is a slight change within the Foreword and Annex Zs ofEN ISO 14971:2012. This part of the chapter will only be focusing on the clauses of ISO 14971:2007 which is exactly the same as EN ISO 14971:2012(Chan & Tong, 2013).…”

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confidence: 99%

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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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Section: Risk Management Planmentioning

confidence: 99%

Section: Risk Analysis (Clause 4)mentioning

confidence: 99%

Section: Production and Post-production Information (Clause 9)mentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Responsible and Regulatory Conform Machine Learning for Medicine: A Survey of Challenges and Solutions

Petersen

Potdevin

Mohammadi³

et al. 2022

IEEE Access

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project, see www.ki-sigs.de, which is funded by the German Federal Ministry for Economic Affairs and Climate Action (BMWK) and involves several universities, research institutions and private companies in northern Germany. Researchers YP, SB and LP are employed through funding from the KI-SIGS project. Neither the funding agency nor the involved private companies have had any influence on the planning and design of this survey, the writing of the manuscript, or the publication process. This research was conducted while EP was at Universität zu Lübeck.

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ISO 14971: Application of Risk Management to Medical Devices

Cited by 2 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

Responsible and Regulatory Conform Machine Learning for Medicine: A Survey of Challenges and Solutions

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