ISO 13485, FDA's QSR, CMDR, MDD: Seeking Correlation Matrix

D

Dan LaBelle

#1
Hello hello,
Working for a Medical Device company that designs, manufactures, and distributes devices throughout the world, there are 4 key standards requirements that need to be compliant to as of today anyways. As an auditor, I must ensure that my organization is compliant to them and make sure that I am covering all applicable elements of each standard during each audit that I conduct.

My question is: does anyone know of or have an example of a Matrix that compares ISO 13485: 1996/2003, FDA QSR requirements, Canadian Medical Device Requirements (CMDR), and the Medical Device Directives (MDD) in one document. It would be a helpful tool and also proof to our external auditors that our internal audit system is covering all applicable requirements during internal audits.

I have attached my current matrix that doesn't include CMDR and MDD. I have been working on adding both these requirements but am having difficulties because of the semantic nature of how these requirements have been written. Another words, CMDR written by Canadians. MDD written by the European Union and they both have their own way of writing things in a long novel style.

Thanks, Look forward to hearing from you all.
 

Attachments

Elsmar Forum Sponsor

Al Rosen

Staff member
Super Moderator
#2
Dan LaBelle said:
Hello hello,
Working for a Medical Device company that designs, manufactures, and distributes devices throughout the world, there are 4 key standards requirements that need to be compliant to as of today anyways. As an auditor, I must ensure that my organization is compliant to them and make sure that I am covering all applicable elements of each standard during each audit that I conduct.

My question is: does anyone know of or have an example of a Matrix that compares ISO 13485: 1996/2003, FDA QSR requirements, Canadian Medical Device Requirements (CMDR), and the Medical Device Directives (MDD) in one document. It would be a helpful tool and also proof to our external auditors that our internal audit system is covering all applicable requirements during internal audits.

I have attached my current matrix that doesn't include CMDR and MDD. I have been working on adding both these requirements but am having difficulties because of the semantic nature of how these requirements have been written. Another words, CMDR written by Canadians. MDD written by the European Union and they both have their own way of writing things in a long novel style.

Thanks, Look forward to hearing from you all.
Hi Dan, welcome to the Cove.

You can find what you're looking for by serching (At the top of every page) the Cove. I know that I posted a matrix comparison of the QSR to ISO 9k2k here http://elsmar.com/Forums/showthread.php?t=6160&page=2&pp=20.

I also believe there was another matrix posted including iso 13485. The Canadian requirements haven't been included, but are similar to the EU MDD requirements (i.e. vigilence reporting). I'm not in the office right now, but I have some more material on the CMDR there. In the mean time you may want to look at this, if you haven't already done so.

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/cmdcas_13485audit_revdr_e.html#annexa
 
D

Dan LaBelle

#3
Thanks for the links. I've come to the understanding that the CMDR is the same requirements as ISO 13485 but with additional requirements such as Manditory Reporting, Distribution Records, Establishment Licenses, etc. The MDD requirements are about the same but have other additional requirements such as the Technical Files, Declarations, CE Marks, etc. I think in the end I will continue to attempt to add the MDD and CMDR requirements in one matrix and post it to this thread for others to use or evaluate. I orginally wanted this matrix to be a one page document with all requirements cross referenced so in one audit everything can be covered easily. I'm thinking this may need to be more than one page. Oh well.
 
B

brandwood

#4
Have you looked at the GHTF Guidance document which do this?

Have a look through the GHTF website for current updates www.ghtf.org

Also keep a look out for ISO TR 14283 which is under final stages of publication which includes a coparison matrix prepared by the tregulators.

Arthur Brandwood
 
C

compliance - 2006

#6
Dan LaBelle said:
Hello hello,
Working for a Medical Device company that designs, manufactures, and distributes devices throughout the world, there are 4 key standards requirements that need to be compliant to as of today anyways. As an auditor, I must ensure that my organization is compliant to them and make sure that I am covering all applicable elements of each standard during each audit that I conduct.

My question is: does anyone know of or have an example of a Matrix that compares ISO 13485: 1996/2003, FDA QSR requirements, Canadian Medical Device Requirements (CMDR), and the Medical Device Directives (MDD) in one document. It would be a helpful tool and also proof to our external auditors that our internal audit system is covering all applicable requirements during internal audits.

I have attached my current matrix that doesn't include CMDR and MDD. I have been working on adding both these requirements but am having difficulties because of the semantic nature of how these requirements have been written. Another words, CMDR written by Canadians. MDD written by the European Union and they both have their own way of writing things in a long novel style.

Thanks, Look forward to hearing from you all.

Here's what I have done. I put a lot of work into it and I think it's pretty complete. Does this help you? I created it for internal auditing of our processes. It crossreferences 13485:2003, MDD, AIMD, QSR, CMDCAS, and ISO 9000:2000 (the last of which we don't comply, so some sections may be crossed out.)
 
A

ADDADD

#7
crossreferences 13485:2003, MDD, AIMD, QSR, CMDCAS, and ISO 9000:2000

compliance said:
Here's what I have done. I put a lot of work into it and I think it's pretty complete. Does this help you? I created it for internal auditing of our processes. It crossreferences 13485:2003, MDD, AIMD, QSR, CMDCAS, and ISO 9000:2000 (the last of which we don't comply, so some sections may be crossed out.)
Dear Compliance,

Because I'm working in the Netherlands (Europe) and our Quality system has to comply with MDD, I'm very interested in your file. Unfortunately I cannot find it! :eek:

Please help me...

Regards,
ADDADD
 
C

celeo

#8
International Reg-requirements & Q-system requirements

Further to the Q-systems cross reference chart that I posted earlier there is also the regulatory system cross reference that I attach now.
It is not a easy to point the regulatory requirements directly to a Q-system clause as they simply do not match up.
:magic: However the FDA/MDD/CMDR/Australia Regs Excel spreadsheet does go a long way to help understand the differences.
 

Attachments

C

compliance - 2006

#9
ADDADD said:
Dear Compliance,

Because I'm working in the Netherlands (Europe) and our Quality system has to comply with MDD, I'm very interested in your file. Unfortunately I cannot find it! :eek:

Please help me...

Regards,
ADDADD
:eek: I'm not sure how to attach my file again. I have attached it in the following thread and apparently cannot attach again. If you can't get to it on this thread, I can send it directly to you through email if you would like? :)
Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets
 
R

rells

#10
compliance said:
:eek: I'm not sure how to attach my file again. I have attached it in the following thread and apparently cannot attach again. If you can't get to it on this thread, I can send it directly to you through email if you would like? :)
Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets
If not too much trouble would appreciate you emailing that lost attachment my direction as well!

rellsworth(at)curonmedical(dot)com

Gracias!
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
V Determining FDA 820 (registration) vs ISO 13485 - Supplier gives us the kit ISO 13485:2016 - Medical Device Quality Management Systems 1
L Digitalization of documents - FDA and ISO 13485 Other Medical Device Related Standards 1
E MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP Canada Medical Device Regulations 9
B Classes/ Online Training on ISO 13485:2016 and FDA QSR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 5
M Medical Device News FDA News - 26-09-18 - FDA Reveals Vision for the Transition to ISO 13485 Other US Medical Device Regulations 1
Sidney Vianna FDA plans to use ISO 13485 for Medical Devices Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
V Differences between ISO 13485 & FDA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
cscalise Legal Obligation to report ISO 13485 Finding to FDA? Registrars and Notified Bodies 1
Y ISO 13485:2003 &FDA QSR (21 CFR 820) Quality Manual,34 Procedures and Form Book, Video, Blog and Web Site Reviews and Recommendations 8
M ISO 13485 and Class 1 Medical Device - FDA thinking ISO 13485:2016 - Medical Device Quality Management Systems 14
Q Need Outsourced ISO 13485/FDA Internal Auditor for a Medical Device Company Internal Auditing 3
R ISO 13485 vs FDA Requirement question about when ISO 13485 Certification is Required ISO 13485:2016 - Medical Device Quality Management Systems 4
M FDA Acceptance of ISO 13485 Reports from a Recognized International Program Other US Medical Device Regulations 4
E FDA and ISO 13485 - Once we get our 510K are we free to sell product? US Food and Drug Administration (FDA) 2
S Packaging and Label Change Requirements - ISO 13485/FDA 21CFR820 ISO 13485:2016 - Medical Device Quality Management Systems 3
S Will you use the FDA's ISO 13485 Voluntary Report Submission Program? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
M ISO 13485 and FDA QSR Employee Training Requirements when Procedures are Revised Manufacturing and Related Processes 5
F ISO 13485 & FDA Requirements - What kinds of software require validation? ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Books that have a combination of ISO 13485 and FDA Title 21 CFR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 9
A Document Approval Requirements in an ISO 13485 and FDA System Document Control Systems, Procedures, Forms and Templates 7
M Do basic Microscopes require Calibration per FDA and ISO 13485 General Measurement Device and Calibration Topics 10
A Purchasing Information Requirements - ISO 13485 Clause 7.4.2 and FDA QSR Supplier Quality Assurance and other Supplier Issues 2
Q ISO 13485, ISO 9001 QMS and FDA Requirements - Process vs. Compliance Approach? ISO 13485:2016 - Medical Device Quality Management Systems 4
V ICH Q10 vs. ISO 9001 vs. ISO 13485 and FDA 210-211 - Differences US Food and Drug Administration (FDA) 9
V Advantages of ISO 13485 or 9001 Certification for FDA Approved and Regulated site ISO 13485:2016 - Medical Device Quality Management Systems 3
T FDA vs. ISO 13485 - Are FDA Documents for Devices accepted in Europe ISO 13485:2016 - Medical Device Quality Management Systems 3
T Matrix for Documented Procedures (US FDA Part 820, ISO 13485 and ISO 9001) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Is Annual Revalidation Required? ISO 13485 and FDA ISO 13485:2016 - Medical Device Quality Management Systems 11
I ISO 13485 and FDA 21 CFR 820 Regulation - Writing my QA Manual ISO 13485:2016 - Medical Device Quality Management Systems 2
Q ISO 13485, FDA's QSR, CMDR, MDD: Seeking Internal Audit Correlation Matrix Various Other Specifications, Standards, and related Requirements 3
E Does European Manufacturer with ISO 13485 need QSR820 for FDA registration? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
A Customer Supplied Product & Certifications - Drop Ship - FDA and ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
D Administrative personnel training - ISO 13485 and FDA QSR requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
D Upcoming FDA ISO 13485 audit guidance (draft version) ISO 13485:2016 - Medical Device Quality Management Systems 19
D Lean SCAR Process and Form needed - ISO 13485 and FDA ISO 13485:2016 - Medical Device Quality Management Systems 8
C Technical Documentation, DMR, ISO 13485 vs. FDA, STED Document Control Systems, Procedures, Forms and Templates 10
C Structure and Content of DMR / Technical Documentation (FDA vs. ISO 13485)? Document Control Systems, Procedures, Forms and Templates 6
N Upgrading ISO 13485:2003 QMS to FDA 21 CFR 820 Compliance ISO 13485:2016 - Medical Device Quality Management Systems 1
J ISO 13485, Canadian MDR and FDA 21CFR820 Comparison Matrix ISO 13485:2016 - Medical Device Quality Management Systems 14
H Sample Design Plan that complies with FDA QSR, ISO 13485 & 14971. ISO 14971 - Medical Device Risk Management 5
G Comparison of ISO 13485, FDA and JGMP ISO 13485:2016 - Medical Device Quality Management Systems 37
M ISO 13485, MDD & FDA Certification Body Selection Registrars and Notified Bodies 7
Q Looking for Best ISO 13485/FDA QSR Quality System Development Software Quality Assurance and Compliance Software Tools and Solutions 4
R Guidance for 'Maintaining Compliance to 820 - FDA and ISO 13485:2003 ISO 13485:2016 - Medical Device Quality Management Systems 8
J ISO 13485 vs. FDA QSR (21 CFR Part 820) - Differences - Includes Spreadsheets ISO 13485:2016 - Medical Device Quality Management Systems 64
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom