Risk management assessment of a medical device based on ISO 14971 standard /

Risk management assessment of a medical device based on ISO 14971 standard /

Show other versions (1)

Project Paper (Sarjana Muda Kejuruteraan (Mekanikal)) - Universiti Teknologi Malaysia, 2019

Bibliographic Details
Main Authors:	Siti Nurasyikin Ramlan, 1996-, author 625754, Aini Zuhra Abdul Kadir supervisor 408883, Fakulti Kejuruteraan. Sekolah Kejuruteraan Mekanikal 619080
Format:
Language:	eng
Published:	Johor Bahru, Johor : Universiti Teknologi Malaysia, 2019
Subjects:	Medical instruments and apparatus Risk management

Similar Items

Risk management assessment of a medical device based on ISO 14971 standard /
by: Siti Nurasyikin Ramlan, 1996-, author 625754
Published: (2019)

Design evaluation and functional analysis of protected plastic enclosure for medical application using fused deposition modeling technology /
by: Abdullah SH Mohamad, 1993-, author 626206, et al.
Published: (2019)

Mechanical test and analysis of 3D printed polymer enclosure for medical application /
by: Norsyahirah Ali, 1996-, author, et al.
Published: (2019)

Reliable design of medical devices /
by: 313661 Fries, Richard C.
Published: (1997)

Reliable design of medical devices /
by: 313661 Fries, Richard C.
Published: (2006)

Medical devices - application of risk management to medical devices (first revision) (ISO 14971:2007, IDT)
by: Department of Standards Malaysia
Published: (2009)

Medical devices : use and safety /
by: 200071 Jacobson, Bertil, et al.
Published: (2007)

Medical device epidemiology and surveillance /
by: Brown, S. Lori, et al.
Published: (2007)

Medical devices. Quality management systems. Requirements for regulatory purposes (ISO 13485:2016+A11:2021) /
by: British Standards Institution, owner 8096
Published: (2021)

Design controls for the medical device industry /
by: 372224 Teixeira, Marie B., et al.
Published: (2003)

Handbook of medical device design /
by: Fries, Richard C.
Published: (2001)

Usability testing of medical devices /
by: 281492 Wiklund, Michael E., et al.
Published: (2011)

Information exchange for medical devices /
by: Pallikarakis, N., et al.
Published: (1996)

Web based medical device post market management system/
by: Lim, Geok Li, 1986-, author, et al.
Published: (2010)

Web based medical device post market management system /
by: Lim, Geok Li, 1986-, author, et al.
Published: (2010)

Medical devices : surgical and image-guided technologies /
by: Culjat, Martin, 1977- 541382, et al.
Published: (c201)

Guidelines for failure modes and effects analysis for medical devices /
Published: (2003)

The medical device R & D handbook /
by: Kucklick, Theodore R.
Published: (2006)

Evaluation of medical devices for biological hazards
by: 8096 British Standards Institution

Medical device design : innovation from concept to market /
by: 296998 Ogrodnik, Peter J.
Published: (2013)

Guidelines for failure modes and effects analysis for medical devices [compact disc] /
Published: (2003)

Maintenance programme for active medical devices in Johor /
by: 225054 Tan, Chuan Siong, et al.
Published: (2007)

Handbook of active materials for medical devices : advances and applications /
by: Lantada, Andres Diaz, editor
Published: (2012)

Surface engineered surgical tools and medical devices /
by: Jackson, Mark J., et al.
Published: (2007)

Maintenance programme for active medical devices in Johor [electronic resource] /
by: 225054 Tan, Chuan Siong, et al.
Published: (2007)

Design and development of medical electronic instrumentation : a practical perspective of the design, construction, and test of medical devices /
by: 430652 Prutchi, David, et al.
Published: (2005)

Sterilization methods for medical devices : physical, chemical and high energy radiation /
by: 401288 Scycher, Michael, et al.
Published: (1989)

The FDA and worldwide quality system requirements guidebook for medical devices /
by: 241799 Daniel, Amiram, et al.
Published: (2008)

Joining and assembly of medical materials and devices /
by: Zhou, Y. Norman, et al.
Published: (2013)

Mechanical test and analysis of 3D printed polymer enclosure for medical application /
by: Norsyahirah Ali, 1996-, author
Published: (2019)

Biological evaluation of medical devices - part 14 : identification and quantification of degradation products from ceramics
by: Malaysia. SIRIM Berhad. Department of Standards Malaysia, issuing body, et al.
Published: (2005)

Online guideline of medical devices electrical safety testing and monitoring /
by: 273934 Shahril Azhar Ahmad Shah, et al.
Published: (2007)

Performance evaluation an ozone-based system for medical equipment sterilization /
by: Nur Nabilah Kamarudin, 1995-, author, et al.
Published: (2018)

Online guideline of medical devices electrical safety testing and monitoring [electronic resource] /
by: 273934 Shahril Azhar Ahmad Shah, et al.
Published: (2007)

The medical device R&D handbook /
by: Kucklick, Theodore R.
Published: (2013)

Regulatory affairs for biomaterials and medical devices /
by: Amato, Stephen F., et al.
Published: (2015)

Medical electrical equipment
by: 8096 British Standards Institution, et al.

Medical electrical equipment
by: 8096 British Standards Institution, et al.

Plastics in medical devices : properties, requirements, and applications /
by: Sastri, Vinod R., 1957-
Published: (2010)

Guide to microbiological control in pharmaceuticals and medical devices /
by: Denyer, Stephen P., et al.
Published: (2007)