SBS - The Best Value in QMS software

Guidance for 'Maintaining Compliance to 820 - FDA and ISO 13485:2003

R

race-tmt

#1
FDA and ISO 13485

Hello there!
I am new to medical devices (formally involved/educated QS-9000) and I found a thread which contained a GHTF site which is supposed to contain guidance for 'maintaining compliance to 820 and 13485 in a single QMS'. However, I was unable to access this particular information and I was wondering if anyone knows where it can be found or has a copy of it. I would appreciate it immensely!

By the way, I just wanted to let everyone know how great this forum is...it is certainly helping me make some amount of sense of this puzzle.

Thanks!
Tracey
 
Elsmar Forum Sponsor
A

Aaron Lupo

#2
Tracey-

Welcome! What thread were you looking at? Were you looking for the QSIT manual?
 
R

race-tmt

#3
820-13485

:) Hi there thanks for replying.

I cannot seem to find the thread at the moment but I did print a portion of the page and it was written by Jerome Council, ASQCQA, CQA-Biomedical Auditing. Is it possible to track it by name?

Thanks so much :bigwave:
 
Last edited by a moderator:
A

Aaron Lupo

#4
Tracey-

I looked around and couldn't find anything. If you can tell me a little more about what you are looking for I (or someone else here) might have the information you are looking for.
 
R

race-tmt

#5
Thanks for looking around for me.
I am specifically looking for information regarding a way to structure and word my QMS so that it satisfies both 820 and 13485. If that is in fact possible...
I will attempt to locate the original thread in order to better explain myself.
Tracey
 
A

Aaron Lupo

#6
race-tmt said:
Thanks for looking around for me.
I am specifically looking for information regarding a way to structure and word my QMS so that it satisfies both 820 and 13485. If that is in fact possible...
I will attempt to locate the original thread in order to better explain myself.
Tracey
Ok now that I know what you are looking for that is pretty easy. Couple of questions, are you ISO certified now and I am guessing you will be looking for Certification to ISO 13485:2003? Do you have a current Quality manual I could take a look at, I can also pass along a sanatized copy of a QM that is compliant with ISO and FDA if you would like to see it.
 
R

race-tmt

#7
I found the thread. July 4th 2002 by user counj3fl
I found it by looking him up and then browsing all of his posts.

We are currently FDA compliant. Not yet ISO I am working on ISO 13485. I have written the QM and just want to figure out how to make life easier.... :vfunny:
 

Al Rosen

Staff member
Super Moderator
#9
race-tmt said:
Hello there!
I am new to medical devices (formally involved/educated QS-9000) and I found a thread which contained a GHTF site which is supposed to contain guidance for 'maintaining compliance to 820 and 13485 in a single QMS'. However, I was unable to access this particular information and I was wondering if anyone knows where it can be found or has a copy of it. I would appreciate it immensely!

By the way, I just wanted to let everyone know how great this forum is...it is certainly helping me make some amount of sense of this puzzle.

Thanks!
Tracey
I found this old document. It's aligned with the old version of 13485.
 

Attachments

Thread starter Similar threads Forum Replies Date
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
M Informational USFDADraft Guidance – Accreditation Scheme for Conformity Assessment (ASCA) Pilot Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom