SBS - The Best Value in QMS software

IAEG Guidance Document to assist Aerospace Organizations transitioning to 14001:2015

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
Sidney Vianna The creation of the International Aerospace Environmental Group - IAEG AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
N Guidance - Cost of Good Quality Misc. Quality Assurance and Business Systems Related Topics 2
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Sidney Vianna Release of ISO 10013:2021, Quality management systems – Guidance for documented information Other ISO and International Standards and European Regulations 0
M Labelling - Is there a guidance or regulations that specifically defines the 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Guidance for health institutions on in-house manufacture and use UK Medical Device Regulations 1
S Need guidance on project ISO 13485:2016 - Medical Device Quality Management Systems 2
dgrainger Informational MHRA guidance on CE UKNI - Article 5.5 - 2021-02 EU Medical Device Regulations 0
R Quality System Functional Safety Checklist / Guidance IATF 16949 - Automotive Quality Systems Standard 0
K Looking for guidance to write an SOP on Statistical Methodologies? Statistical Analysis Tools, Techniques and SPC 7
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
M Minimum sample size - Guidance and statistical rationale Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
Aymaneh AAMI TIR45 guidance wanted IEC 62304 - Medical Device Software Life Cycle Processes 4
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
D GMDN code update - Canada - Do you know if there is guidance? Canada Medical Device Regulations 0
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 1
dgrainger Informational UK guidance on Device regulation from Jan 2021 published UK Medical Device Regulations 19
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
B EU MDR Perscription product guidance EU Medical Device Regulations 1
John Broomfield Guidance on Safe Working During Covid-19 Pandemic Misc. Quality Assurance and Business Systems Related Topics 5
dgrainger Informational UK guidance on FSNs - May 2020 EU Medical Device Regulations 1
dgrainger Informational UK guidance on FSNs - Published 20 May 2020 UK Medical Device Regulations 1
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
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
J Guidance on manufacturing non-surgical face masks US Food and Drug Administration (FDA) 3
dgrainger Informational MHRA guidance update on withdrawal of Notified Bodies Medical Device and FDA Regulations and Standards News 0
M Advertising medical devices in the U.S - Advertising regulations or guidance documents Other US Medical Device Regulations 3
dgrainger Informational MHRA updated guidance: Clinical investigations of medical devices – guidance for manufacturers Medical Device and FDA Regulations and Standards News 0
rob73 MDCG guidance on class 1 devices and MDR EU Medical Device Regulations 0
U Product Lifecycle Procedure Guidance Design and Development of Products and Processes 7
J CEN/TR 17223:2018 Guidance on the relationship between13485 and MDR.. worth the money?? ISO 13485:2016 - Medical Device Quality Management Systems 3
M Informational EU – Ongoing Guidance development within MDCG Subgroups Medical Device and FDA Regulations and Standards News 1
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
M Informational EU – EMA revised guidance – Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 201 Medical Device and FDA Regulations and Standards News 2
D Performance Qualification per GHTF Guidance Other Medical Device Related Standards 12
M Informational EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 2
dgrainger Informational MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Clinical Decision Support Software Medical Device and FDA Regulations and Standards News 0
M Informational DSVG 04 – Breast Implants – Guidance on the vigilance system for CE-marked medical devices Medical Device and FDA Regulations and Standards News 0
M Informational EU – DSVG 03 – Cardiac Implantable Electronic Devices (CIED) – Guidance on the vigilance system for CE-marked medical devices Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Patient Engagement in Design and Conduct of Medical Device Clinical Investigations Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom