GHTF - Study Group 1 (SG1) - Final Documents issued

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Performance Qualification per GHTF Guidance Other Medical Device Related Standards 12
S IMDRF or still GHTF for STED and other guidance? Other Medical Device and Orthopedic Related Topics 5
J GHTF Incidents - What does unlabeled and labeled mean? Japan Medical Device Regulations 9
H GHTF and IMDRF - Alternative for the STED format EU Medical Device Regulations 5
B Are the GHTF guidance documents still relevant? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 5
J GHTF (Global Harmonization Task Force) SG2 Guidance Documents EU Medical Device Regulations 3
L GHTF/SG3/N15R8 - Process Validation and Risk Analysis ISO 13485:2016 - Medical Device Quality Management Systems 4
E Is GHTF Classification Structure similar to EU MDD Calssification EU Medical Device Regulations 3
Ajit Basrur GHTF Releases many documents on Nov 5, 2012 ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 8
bio_subbu GHTF issues guidance on Adverse Event Data Reporting Standard Other Medical Device Regulations World-Wide 0
bio_subbu GHTF issues revised document "Definitions of ?Medical Device? and ?IVD? Other Medical Device Regulations World-Wide 1
bio_subbu GHTF Proposes New Harmonization of Medical Device Audits Other Medical Device Regulations World-Wide 0
S New GHTF guidance document on Clinical Studies Performance for IVDs Other Medical Device Regulations World-Wide 1
Ajit Basrur GHTF evolves into International Medical Device Regulators' Forum (IMDRF) Other Medical Device Regulations World-Wide 0
V Medical Device Definitions outside GHTF (Global Harmonization Task Force) Other Medical Device Regulations World-Wide 2
P GHTF's (Global Harmonization Task Force) Latest ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 5
S End of GHTF (Global Harmonisation Task Force) Other Medical Device and Orthopedic Related Topics 8
M GHTF (Global Harmonization Task Force) "Archived" Document question EU Medical Device Regulations 3
bio_subbu GHTF Issues Draft Guidance Document on UDI System for Medical Devices Other Medical Device Related Standards 1
bio_subbu GHTF Issues - Medical Devices - Guidance on CAPA and related QMS processes Other Medical Device Related Standards 1
bio_subbu GHTF issued SG4 Final documents ? Audits of Manufacturer Control of Suppliers, etc. Other Medical Device Related Standards 3
V In search of GHTF SG4/N84 ISO 13485:2016 - Medical Device Quality Management Systems 2
Ajit Basrur GHTF (Global Harmonization Task Force) release 2 final documents Other Medical Device Regulations World-Wide 2
S Performance Qualification: GHTF PQ vs. FDA PPQ 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M New GHTF proposed documents - CAPA and Audits of Control of Suppliers Other Medical Device and Orthopedic Related Topics 4
Ajit Basrur Proposed documents from GHTF (Global Harmonization Task Force) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
bio_subbu GHTF - Guidance on QMS Audits at Multiple Sites / Regulatory Auditing Strategy Other Medical Device Related Standards 1
bio_subbu GHTF definition of Manufacturer, Authorized Representative, Distributor and Importer Other Medical Device and Orthopedic Related Topics 2
Ajit Basrur GHTF - Guidance on the Control of Products and Services Other Medical Device and Orthopedic Related Topics 0
M GHTF, next-gen MDD...headed in the same direction? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T Technical File, GHTF's STED and Recommended Content of 510(k) Comparison/Relationship Document Control Systems, Procedures, Forms and Templates 1
Ajit Basrur GHTF (Global Harmonisation Task Force) - Guidelines for Regulatory Auditing ISO 13485:2016 - Medical Device Quality Management Systems 0
S Process Validation from an FDA standpoint - The GHTF document ISO 13485:2016 - Medical Device Quality Management Systems 6
D What are the acceptance criteria/requirements for Stability Study? General Measurement Device and Calibration Topics 7
S 95% UCL - Attaching an excel for recovery study Statistical Analysis Tools, Techniques and SPC 0
Nihls MSA Study Type 1 (CMM) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
M MSA Study Type 1 not capable. We are at the limit. And manufacturing wants to continue producing. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
cnbrosa Study Type 1 on a CMM using a measuring support Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
M Lean: Conducting Capacity Study, calculating Cycle times on laser cutting machines Lean in Manufacturing and Service Industries 2
P MSA study for visual system with artifical inteligence Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
A Capability Study - in the beginning of your career what should you have known about the tool Quality Tools, Improvement and Analysis 11
Q Capability study with a minimum spec Statistical Analysis Tools, Techniques and SPC 8
E Use of OQ cleared batch for stability and clinical study use ISO 13485:2016 - Medical Device Quality Management Systems 0
S Study sign off question / responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 9001:2015 case study sample ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Case study help as per ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Case study resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1

Similar threads

Top Bottom