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Journal Articles

Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience—Part 2: Medical Device Ecosystem and Policy

Jan B. Pietzsch, Marta G. Zanchi, John H. Linehan

Publisher: ASME

J. Med. Devices. June 2013, 7(2): 021003.

Paper No: MED-12-1074

https://doi.org/10.1115/1.4023131

Published Online: June 24, 2013

View Article titled, Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience—Part 2: Medical Device Ecosystem and Policy

Topics: Food and Drug Administration, Medical devices, Clearances (Engineering)

Journal Articles

Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience

Jan B. Pietzsch, Marta G. Zanchi, John H. Linehan

Publisher: ASME

J. Med. Devices. June 2012, 6(2): 021015.

https://doi.org/10.1115/1.4006781

Published Online: May 24, 2012

View Article titled, Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience

Topics: Food and Drug Administration, Medical devices, Regulations

Journal Articles

A Case Study of Physician Interaction in the Medical Device Development Process

Lauren Aquino Shluzas, John H. Linehan, Larry J. Leifer

Publisher: ASME

J. Med. Devices. June 2010, 4(2): 027516.

https://doi.org/10.1115/1.3442793

Published Online: August 10, 2010

View Article titled, A Case Study of Physician Interaction in the Medical Device Development Process

Topics: Medical devices, Biomedical equipment, Biomedicine, Design, Industrial research, Performance, Product design, Risk perception, Surveillance, Teams

Journal Articles

Stage-Gate Process for the Development of Medical Devices

Jan B. Pietzsch, Lauren A. Shluzas, M. Elisabeth Paté-Cornell, Paul G. Yock, John H. Linehan

Publisher: ASME

J. Med. Devices. June 2009, 3(2): 021004.

https://doi.org/10.1115/1.3148836

Published Online: June 17, 2009

View Article titled, Stage-Gate Process for the Development of Medical Devices

Topics: Design, Gates (Closures), Medical devices, Drugs, Innovation

Journal Articles

Review of U.S. Medical Device Regulation

Jan B. Pietzsch, Lauren M. Aquino, Paul G. Yock, M. Elisabeth Paté-Cornell, John H. Linehan

Publisher: ASME

J. Med. Devices. December 2007, 1(4): 283–292.

https://doi.org/10.1115/1.2812429

Published Online: October 19, 2007

View Article titled, Review of U.S. Medical Device Regulation

Topics: Food and Drug Administration, Frequency-domain analysis, Medical devices, Safety, Risk, Design, Drugs

Journal citation

NARROW

Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience—Part 2: Medical Device Ecosystem and Policy

Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience

A Case Study of Physician Interaction in the Medical Device Development Process

Stage-Gate Process for the Development of Medical Devices

Review of U.S. Medical Device Regulation

ASME Journals

ASME Conference Proceedings

ASME eBooks

Resources

Opportunities

Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience—Part 2: Medical Device Ecosystem and Policy

Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience

A Case Study of Physician Interaction in the Medical Device Development Process

Stage-Gate Process for the Development of Medical Devices

Review of U.S. Medical Device Regulation

ASME Journals

ASME Conference Proceedings

ASME eBooks

Resources

Opportunities

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