How to consider the relevant standards during development of ISO13482:2016 for IVD manufacturing Blood grouping

#1
Seeking guidance on the following relevant standards to ensure need and requirements of the standard ISO 13485;2016 clause wise are met ;

1. ISO 13485:2016 - Requirements for regulatory purposes
2. EN 13641: 2002 - Elimination or reduction of risk of infections related to IVD reagents.
3. EN ISO 14671: 2012 - Application of risk management to medical devices
4. EN 13612:2002 - Performance evaluation of IVD medical devices.
5. EN 23640:2013 - IVD-MD- Evaluations of stability of IVD reagents.
6. EN 15223-1:2012 : MD symbols to be used with medical device label.
7. EN ISO 18113-1, -2 " 2011 IVD-MD- Information supplied by the manufacturer (labeling)

The medical device is classified as;
IVDs in Annex II List A – High Risk
For devices under Annex II List A, manufacturers must follow either Annex IV, or alternatively Annexes V and VII (they cannot follow Annexes V and VI). In addition, the Notified Body must verify the product meets the Common Technical Specification (CTS) and must release each batch of product before it can be placed on the European market. The batch release often requires testing.
 
Elsmar Forum Sponsor

kj_wilson

Optimistic Global Curmudgeon
#2
Seeking guidance on the following relevant standards to ensure need and requirements of the standard ISO 13485;2016 clause wise are met ;

1. ISO 13485:2016 - Requirements for regulatory purposes
2. EN 13641: 2002 - Elimination or reduction of risk of infections related to IVD reagents.
3. EN ISO 14671: 2012 - Application of risk management to medical devices
4. EN 13612:2002 - Performance evaluation of IVD medical devices.
5. EN 23640:2013 - IVD-MD- Evaluations of stability of IVD reagents.
6. EN 15223-1:2012 : MD symbols to be used with medical device label.
7. EN ISO 18113-1, -2 " 2011 IVD-MD- Information supplied by the manufacturer (labeling)

The medical device is classified as;
IVDs in Annex II List A – High Risk
For devices under Annex II List A, manufacturers must follow either Annex IV, or alternatively Annexes V and VII (they cannot follow Annexes V and VI). In addition, the Notified Body must verify the product meets the Common Technical Specification (CTS) and must release each batch of product before it can be placed on the European market. The batch release often requires testing.
Seeking guidance on the following relevant standards to ensure need and requirements of the standard ISO 13485;2016 clause wise are met ;

1. ISO 13485:2016 - Requirements for regulatory purposes
2. EN 13641: 2002 - Elimination or reduction of risk of infections related to IVD reagents.
3. EN ISO 14671: 2012 - Application of risk management to medical devices
4. EN 13612:2002 - Performance evaluation of IVD medical devices.
5. EN 23640:2013 - IVD-MD- Evaluations of stability of IVD reagents.
6. EN 15223-1:2012 : MD symbols to be used with medical device label.
7. EN ISO 18113-1, -2 " 2011 IVD-MD- Information supplied by the manufacturer (labeling)

The medical device is classified as;
IVDs in Annex II List A – High Risk
For devices under Annex II List A, manufacturers must follow either Annex IV, or alternatively Annexes V and VII (they cannot follow Annexes V and VI). In addition, the Notified Body must verify the product meets the Common Technical Specification (CTS) and must release each batch of product before it can be placed on the European market. The batch release often requires testing.


=-=-=-= RESPONSE =-=-=-=-=
In general, all of the listed standards could be relevant (useful). A bit more info is needed to answer your question. Feel free to use the forum for our discussion, or respond via "private msgs" if you wish.
  1. What is the Intended Use (Indication for Use) of the Product?
  2. What markets is the product intended (EU, JP, CA, US, ...)?
  3. Is the product (or a very similar, in terms of technology) marketed anywhere (include if it is a research-only) product)?
 
#3
Hi,
1) product are distributed to hospital, blood bank and clinical research.
2) only in Saudi Arabia. In Saudi Arabia, the regulatory body is SFDA ( Saudi Food and Drugs Authority) similar to FDA.
3) Yes.- Reagent kits are processed as per customer's specification and control by "contract manufacturing" and distribution.
 

kj_wilson

Optimistic Global Curmudgeon
#4
It has be a couple of years since I was involved with IVD products in Saudi Arabia, so please double check their regs. I believe that your jurisdiction is structured similar to the EU/JP mode of regulation.

As such, there are two main standards to be concerned with first:
  • ISO 13485:2016
  • ISO 14971:2012 {I think you have a typo in your original post...}

Get your systems for those two in order, then communicate with the SFDA directly about what sort of assurances they want to see to approve your product(s). Then decide if the existing global (ISO) standards are suitable for meeting those requirements.

NB: products used "FOR RESEARCH ONLY" have their own collection of concerns; it possible, it is best to use fully approved human IVD products in clinical research settings (especially if they will be supporting healthcare decisions or used as evidence for approval of other devices/drugs).

Hoping this helps...
 

kj_wilson

Optimistic Global Curmudgeon
#5
I presumed that you have completed the "Essential Principles Checklist" (GHTF/IMDRF) required by SFDA, if not, start there.
 
#7
It has be a couple of years since I was involved with IVD products in Saudi Arabia, so please double check their regs. I believe that your jurisdiction is structured similar to the EU/JP mode of regulation.

As such, there are two main standards to be concerned with first:
  • ISO 13485:2016
  • ISO 14971:2012 {I think you have a typo in your original post...}

Get your systems for those two in order, then communicate with the SFDA directly about what sort of assurances they want to see to approve your product(s). Then decide if the existing global (ISO) standards are suitable for meeting those requirements.

NB: products used "FOR RESEARCH ONLY" have their own collection of concerns; it possible, it is best to use fully approved human IVD products in clinical research settings (especially if they will be supporting healthcare decisions or used as evidence for approval of other devices/drugs).

Hoping this helps...
Thanks for the guidance. Let me review and revert back, in case need your support for consultancy.
 
Thread starter Similar threads Forum Replies Date
J Mislabeling - Consider this an FDA notified recall? CFR 806.10 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R When does the FDA consider a component a medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
Q Criteria for print shop - How do you consider the cycle time in a print shop? Lean in Manufacturing and Service Industries 21
M Medical Device News FDA News - 14-09-18 - Benefit-Risk Factors to Consider for Substantial Equivalence Other US Medical Device Regulations 0
T Question: Do we consider 60601-1-2 (4th ed) EMC testing a mode for a diagnostic port? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
Q What to consider in 6.4 work environment? ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Implantable Medical Device Consignment Stock - What to consider? ISO 13485:2016 - Medical Device Quality Management Systems 3
Ajit Basrur FDA issues Guidance Document - Benefits-Risks Factors to consider for 510(K) US Food and Drug Administration (FDA) 1
K Can we consider Operating System as OTS (Off The Shelf) Software? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K Can I consider My medical Application as MDDS ? Other US Medical Device Regulations 1
P Is it necessary to consider ISO 22002-1 for the implementation of ISO 22000 Food Safety - ISO 22000, HACCP (21 CFR 120) 3
G Points to consider while defining the Quality Policy AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 11
D What Factors to consider to determine the Number of Auditors Internal Auditing 3
M Machine Feature: Is it possible to consider it Error Proofing? FMEA and Control Plans 6
R Informational How to consider the Working Voltage for splitting 2MOPP IEC 60601 - Medical Electrical Equipment Safety Standards Series 39
T Pilot's Checklist for Six Sigma - Steps to Consider when Initiating Projects Six Sigma 3
T Does FDA consider Flow Charts sufficient instruction for SOPs? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
K If auditor fails to consider something which is material to the outcome of the audit? Internal Auditing 19
N Note interpretation - Ensure that the preservation of the product has been consider ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A How to write Quality Manual? Point to consider Quality Management System (QMS) Manuals 2
S Do you consider 'unintended' process output(s) while mapping a process? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Sidney Vianna Tough talk on Detroit Three doesn't consider suppliers World News 0
E Do you consider this a Top Management Nonconformity? Nonconformance and Corrective Action 19
S Should we consider Precision of Machine Reading when setting Inspection Specs? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
T Can I consider Reliability Test Plan part of the DVP&R, or the other way round Reliability Analysis - Predictions, Testing and Standards 3
D Should low volume supplier PPM comparisons consider level of opportunity for error? Quality Tools, Improvement and Analysis 2
S Painting on Floor of Machine Shop - What Aspects/Impacts and Hazards to consider? Miscellaneous Environmental Standards and EMS Related Discussions 10
S CSQE : Do they consider the sw development ?Decision making? experience? Professional Certifications and Degrees 1
P What factors should I consider so as to check how "lean" a company is? Lean in Manufacturing and Service Industries 12
Marc Things to consider in a Beer FMEA - Beer Troubleshooting FMEA and Control Plans 7
Marc Where would you retire? Would you consider becoming an 'Expat'? Immigration and Expatriate Topics 29
Casana How to select a consultant? What criteria to consider and look for when looking Consultants and Consulting 5
Govind Metrology Laboratory 'Classes' - Atmospheric, Ergonomic and Other Factors to consider General Measurement Device and Calibration Topics 6
arios Gage R&R analysis - Do I have to consider the sample specifications? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
RoxaneB Several Key Indicators a Company Should Consider Using Misc. Quality Assurance and Business Systems Related Topics 40
T Do You Consider Your Quality Policy Valuable to your Organization? (Poll) Other ISO and International Standards and European Regulations 44
I FMEA Issue - Consider all inspections that we have like a processes? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
M How can we encourage our supplier base to consider ISO14001 Supplier Quality Assurance and other Supplier Issues 2
Richard Regalado Informational ISO makes available relevant BCMS standards free for online access Business Continuity & Resiliency Planning (BCRP) 5
D BS EN 62304 - Medical-Relevant Data C.5 - Definition of IEC 62304 - Medical Device Software Life Cycle Processes 5
I ISO 9001:2015 Section 9.3.2 C1 "customer satisfaction and feedback from relevant interested parties" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
I ISO-9001:2015 and "Relevant Parties" Management Review Meetings and related Processes 2
Ed Panek Relevant questions on Substantial Change Form CE Marking (Conformité Européene) / CB Scheme 3
Q Connecting AS9100 D Clause 4.2 to 9.3.2 b - Interested parties and relevant issues AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 24
C Are zero defect sampling plans relevant to AS9120B Distributor AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
T Relevant internal and external communication - ISO 9001:2015 section 7.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
E IEC 60601-2-57 item 201.12.4.2 - Indication of parameters relevant to safety IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
H CER - Considering similar device/other medical devices for as relevant literature CE Marking (Conformité Européene) / CB Scheme 4
Q Thoughts on Communications relevant to the Quality Management System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J What does "other relevant management roles" include? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Similar threads


















































Top Bottom