Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation

Biomaterials, Medical Devices, and Combination Products ◽

10.1201/b19086-3 ◽

2015 ◽

pp. 11-44

Keyword(s):

Medical Device ◽

Safety Evaluation ◽

Regulatory Aspects

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Regulatory Aspects and Strategy in Medical Device and Bio Materials Safety Evaluation

Safety Evaluation in the Development of Medical Devices and Combination Products, Third Edition ◽

10.1201/9781439809488-3 ◽

2008 ◽

pp. 7-26

Keyword(s):

Medical Device ◽

Safety Evaluation ◽

Regulatory Aspects

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Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation

Integrated Safety and Risk Assessment for Medical Devices and Combination Products ◽

10.1007/978-3-030-35241-7_2 ◽

2019 ◽

pp. 19-56

Author(s):

Shayne C. Gad

Keyword(s):

Medical Device ◽

Safety Evaluation ◽

Regulatory Aspects

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Regulatory aspects and strategy in medical device and bio materials safety evaluation

Regulatory Toxicology, Second Edition ◽

10.1201/9781420025187.ch4 ◽

2001 ◽

Author(s):

Shayne Gad

Keyword(s):

Medical Device ◽

Safety Evaluation ◽

Regulatory Aspects

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Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation

Biomaterials, Medical Devices, and Combination Products ◽

10.1201/b19086-5 ◽

2015 ◽

pp. 34-67

Keyword(s):

Medical Device ◽

Safety Evaluation ◽

Regulatory Aspects

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Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation

Regulatory Toxicology ◽

10.1201/9780429464737-4 ◽

2018 ◽

pp. 83-112

Author(s):

Shayne C. Gad

Keyword(s):

Medical Device ◽

Safety Evaluation ◽

Regulatory Aspects

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Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation

Safety Evaluation in the Development of Medical Devices and Combination Products, Third Edition ◽

10.1201/9781439809488.ch2 ◽

2001 ◽

Keyword(s):

Medical Device ◽

Safety Evaluation ◽

Regulatory Aspects

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LRT Methods in Medical Device Safety Evaluation

Signal Detection for Medical Scientists ◽

10.1201/9780429259753-11 ◽

2021 ◽

pp. 141-174

Author(s):

Ram Tiwari ◽

Jyoti Zalkikar ◽

Lan Huang

Keyword(s):

Medical Device ◽

Safety Evaluation ◽

Medical Device Safety

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Artificial intelligence (AI) impacting diagnosis of glaucoma and understanding the regulatory aspects of AI-based software as medical device

Computerized Medical Imaging and Graphics ◽

10.1016/j.compmedimag.2020.101818 ◽

2021 ◽

Vol 87 ◽

pp. 101818

Author(s):

Bala Prabhakar ◽

Rishi Kumar Singh ◽

Khushwant S. Yadav

Keyword(s):

Artificial Intelligence ◽

Medical Device ◽

Regulatory Aspects

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Safety Evaluation and Regulatory Aspects

Common Fragrance and Flavor Materials ◽

10.1002/9783527693153.ch5 ◽

2016 ◽

pp. 267-270

Keyword(s):

Safety Evaluation ◽

Regulatory Aspects

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Proposal and Application of Security/Safety Evaluation Method for Medical Device System that Includes IoT

Proceedings of the 2018 VII International Conference on Network, Communication and Computing - ICNCC 2018 ◽

10.1145/3301326.3301330 ◽

2018 ◽

Author(s):

Takuo Hayakawa ◽

Ryoichi Sasaki ◽

Hiroshi Hayashi ◽

Yuji Takahashi ◽

Tomoko Kaneko ◽

...

Keyword(s):

Medical Device ◽

Evaluation Method ◽

Safety Evaluation

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