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Journal Articles

A Not-Motorized Implantable Device for Partial Circulatory Support: A Proof of Concept Experiment

Gian Luca Martinelli, Galdino Barbieri, Philippe Caimmi

Publisher: ASME

J. Med. Devices. December 2018, 12(4): 044502.

Paper No: MED-18-1001

https://doi.org/10.1115/1.4041263

Published Online: August 28, 2018

View Article titled, A Not-Motorized Implantable Device for Partial Circulatory Support: A Proof of Concept Experiment

Topics: Circuits, Computer software, Cycles, Feedback, Flow (Dynamics), Flowmeters, Food and Drug Administration, Heart failure, Instrumentation, Pressure

Journal Articles

Children and Adults With Rare Diseases Need Innovative Medical Devices

Vasum Peiris, Kui Xu, Heather L. Agler, Eric A. Chen, Rashmi Gopal-Srivastava, Brian M. Lappin, Debra Y. Lewis, Gayatri R. Rao

Publisher: ASME

J. Med. Devices. September 2018, 12(3): 034701.

Paper No: MED-18-1024

https://doi.org/10.1115/1.4040489

Published Online: July 13, 2018

View Article titled, Children and Adults With Rare Diseases Need Innovative Medical Devices

Topics: Biomedicine, Diseases, Medical devices, Pediatrics, Food and Drug Administration

Journal Articles

Food and Drug Administration's Humanitarian Device Exemption Marketing Approval Pathway: Insights for Developing Devices for Rare Diseases

Gumei Liu, Eric Chen, Debra Lewis, Gayatri Rao

Publisher: ASME

J. Med. Devices. September 2017, 11(3): 034701.

Paper No: MED-16-1350

https://doi.org/10.1115/1.4036333

Published Online: June 27, 2017

View Article titled, Food and Drug Administration's Humanitarian Device Exemption Marketing Approval Pathway: Insights for Developing Devices for Rare Diseases

Topics: Diseases, Drugs, Food and Drug Administration, Food products, Safety, Medical devices

Journal Articles

Augmenting a Clinical Study With Virtual Patient Models: Food and Drug Administration and Industry Collaboration

Adam Himes, Tarek Haddad, Dawn Bardot, On Behalf of the MDIC Mock Presubmission Working Group Participants

Publisher: ASME

J. Med. Devices. September 2016, 10(3): 030947.

Paper No: MED-16-1136

https://doi.org/10.1115/1.4033870

Published Online: August 1, 2016

View Article titled, Augmenting a Clinical Study With Virtual Patient Models: Food and Drug Administration and Industry Collaboration

Topics: Collaboration, Food and Drug Administration, Fracture (Materials), Fracture (Process), Medical devices, Performance

Journal Articles

Introduction to Frontiers Abstracts

Publisher: ASME

J. Med. Devices. December 2013, 7(4): 040201.

Paper No: MED-13-1276

https://doi.org/10.1115/1.4026045

Published Online: December 5, 2013

View Article titled, Introduction to Frontiers Abstracts

Topics: Computer simulation, Food and Drug Administration, Medical devices, Simulation, Modeling, Biomedicine, Computational methods, Engineers, Imaging, Model development

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

Changes to the International Regulatory Environment

Martin McHugh, Fergal McCaffery, Valentine Casey

Publisher: ASME

J. Med. Devices. June 2012, 6(2): 021004.

https://doi.org/10.1115/1.4006592

Published Online: April 26, 2012

View Article titled, Changes to the International Regulatory Environment

Topics: Computer software, Medical devices, Food and Drug Administration

Journal Articles

Development of an ISO 13485 AND FDA QSR Compliant Quality System for an Academic R&D Group: From Concept to Certification

Nancy Paris, Ryan Kanigan

Publisher: ASME

J. Med. Devices. June 2011, 5(2): 027514.

https://doi.org/10.1115/1.3589903

Published Online: June 9, 2011

View Article titled, Development of an ISO 13485 AND FDA QSR Compliant Quality System for an Academic R&D Group: From Concept to Certification

Topics: Biomedical equipment, Food and Drug Administration, Quality management, Surgery

Journal Articles

In-Vitro Tests of a Rapid, Stable-Temperature Recharging System for Implantable Batteries

Leon Radziemski, Arthur Denison, Floyd Dunn, Steve Bell, Eugene Cochran

Publisher: ASME

J. Med. Devices. June 2010, 4(2): 027523.

https://doi.org/10.1115/1.3443227

Published Online: August 10, 2010

View Article titled, In-Vitro Tests of a Rapid, Stable-Temperature Recharging System for Implantable Batteries

Topics: Implantable batteries, Temperature, Biological tissues, Artificial limbs, Biomedical ultrasonics, Food and Drug Administration, Frequency-domain analysis, Lithium-ion batteries, Medical devices, Neurophysiology

Journal Articles

Impacts of Wireless Power on Medical Device Design Safety

J. Schneider, L. Lucke, D. Wessels, T. Schauer

Publisher: ASME

J. Med. Devices. June 2009, 3(2): 027544.

https://doi.org/10.1115/1.3135198

Published Online: July 24, 2009

View Article titled, Impacts of Wireless Power on Medical Device Design Safety

Topics: Biological tissues, Design, Electromagnetic compatibility, Medical devices, Pacemakers, Power systems (Machinery), Safety, Magnetic fields, Resonance, Testing

Journal Articles

Innovation and Design: Pollution Prevention Opportunities in Medical Device Design

J. Becker, C. Zimmer, K. Larson

Publisher: ASME

J. Med. Devices. June 2009, 3(2): 027531.

https://doi.org/10.1115/1.3147387

Published Online: July 9, 2009

View Article titled, Innovation and Design: Pollution Prevention Opportunities in Medical Device Design

Topics: Catheters, Design, Innovation, Medical devices, Pollution control, Sterilization, Food and Drug Administration, Manufacturing, Packaging, Pollution

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

A Not-Motorized Implantable Device for Partial Circulatory Support: A Proof of Concept Experiment

Children and Adults With Rare Diseases Need Innovative Medical Devices

Food and Drug Administration's Humanitarian Device Exemption Marketing Approval Pathway: Insights for Developing Devices for Rare Diseases

Augmenting a Clinical Study With Virtual Patient Models: Food and Drug Administration and Industry Collaboration

Introduction to Frontiers Abstracts

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

Changes to the International Regulatory Environment

Development of an ISO 13485 AND FDA QSR Compliant Quality System for an Academic R&D Group: From Concept to Certification

In-Vitro Tests of a Rapid, Stable-Temperature Recharging System for Implantable Batteries

Impacts of Wireless Power on Medical Device Design Safety

Innovation and Design: Pollution Prevention Opportunities in Medical Device Design

Review of U.S. Medical Device Regulation

ASME Journals

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ASME Journals

ASME Conference Proceedings

ASME eBooks

Resources

Opportunities

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