Focus Online » News

News

Search:  

Latest News | 24 April 2012

GHTF Proposes New Harmonization of Medical Device Audits

0 Likes

The Global Harmonization Task Force (GHTF), a medical device-focused regulatory harmonization organization which counts among its members many of the world’s top regulatory agencies, announced a new [Read More...]

Tags: GHTF Medical Device NGS Nonconformity Grading System proposed QMS QUality Management System RAEIF SG3 SG3(PD)/N19 Standard
Latest News | 26 March 2012

IMDRF Announces Open Stakeholder Meeting

0 Likes

The International Medical Device Regulators Forum (IMDRF), the regulators-only successor organization to the Global Harmonization Task Force (GHTF), is announcing an ‘Open Stakeholder Session’ being [Read More...]

Tags: Australia GHTF IMDRF Medical Device Meeting Stakeholder
Latest News | 16 March 2012

FDA Launches Pilot Program for ISO 13485:2003 Audit Report Submissions

2 Likes

The US Food and Drug Administration (FDA) is announcing the creation of a pilot program to expedite voluntary audit report submissions for medical devices.Under the pilot program, a device [Read More...]

Tags: 13485:2003 CBER CDRH FDA GHTF Guidance ISO Pilot Program
Latest News | 15 March 2012

IMDRF Concludes Inaugural Meeting, Looks to Assume GHTF Duties

1 Likes

The International Medical Device Regulators Forum (IMDRF), the regulators-only presumed successor organization to the Global Harmonization Task Force (GHTF), concluded its first meeting on 1 March. [Read More...]

Tags: GHTF Harmonization IMDRF Medical Device Meeting
Latest News | 2 February 2012

GHTF Releases Proposed Changes to SG5 Clinical Performance Studies for IVDs

0 Likes

The Global Harmonization Task Force released a new proposed document for their Study Group 5 (SG5) category called “Clinical Performance Studies for In Vitro Diagnostic Medical Devices.” The document [Read More...]

Tags: Clinical Performance Studies GHTF IVD Proposed Document SG5