GHTF Pocket Guides

GHTF Guidance Document: SG1-N46:2008, Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices
Available
This handy pocket-sized guide contains the GHTF guidance document on principles of conformity assessment for in vitro diagnostic (IVD) medical devices

GHTF Guidance Document: SG1-N45:2008, Priniciples of In Vitro Diagnostic (IVD) Medical Devices Classification
Available

This handy pocket-sized guide contains the GHTF guidance document on principles of in vitro diagnostic (IVD) medical devices classification.

GHTF Guidance Document: SG1-N11:2008, Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)
Available

This handy pocket-sized guide contains the GHTF guidance document on technical documentation for demonstrating conformity to the essential principles of safety and performance of medical devices (STED).

GHTF Guidance Document: SG1-N44:2008, Role of Standards in the Assessment of Medical Devices
Available
This handy pocket-sized guide contains the GHTF guidance document on the role of standards in the assessment of medical devices.

GHTF Guidance Document: SG1-N15:2006, Principles of Medical Device Classification
Available
This handy pocket-sized guide contains the GHTF guidance document on the principles of medical device classification.

GHTF Guidance Document: SG1-N40:2006, Principles of Conformity Assessment for Medical Devices
Available
This handy pocket-sized guide contains the GHTF guidance document on principles of conformity assessment for medical devices.

GHTF Guidance Document: SG1-N43:2006, Labelling for Medical Devices
Available
This handy pocket-sized guide contains the GHTF guidance document on labeling for medical devices

GHTF Guidance Document: SG1-N29R16:2005, Information Document Concerning the Definition of the Term "Medical Device"
Available
This handy pocket-sized guide contains the GHTF guidance document on the definition of the term "medical device."

GHTF Guidance Document: SG1-N41R9:2006, Essential Principles of Safety & Performance of Medical Devices
Available

This handy pocket-sized guide contains the GHTF guidance document on essential principles of safety & performance of medical devices.

GHTF Guidance Document: SG1-N012R10, Role of Standards in the Assessment of Medical Devices
Available
This handy pocket-sized guide contains the GHTF guidance document on the role of standards in the assessment of medical devices.