SBS - The Best Value in QMS software

IVD Device History Record

SamSx

Registered
#1
Hi all,

I was wondering as part of ISO13485 and 21 CFR 820, what documents would you expect to see in a DHR and what checks would be required on these records prior to QA approval?
Thanks
S
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
At a high level, Design Planning, Risk Management, Design Inputs, Design Outputs, Design Verification, Design Validation, Design Reviews, etc. (pretty much as laid out). If there's software, then there's another set of software-specific docs.

Not sure what you mean by "checks" - all docs are reviewed, approved, and released. Up to you to define more specifics on those activities (and generally is not just QA approval).

Can you be more specific?
 

SamSx

Registered
#3
Hi,

thank you for your reply.

I wasn’t sure what documents to expect in a DHR. Also as a quality auditor, I’d be required to review these documents and my question is, what types of things would I be expected to audit in these documents. What sort of things will I audit to ensure compliance in these documents?
I hope that makes sense

thanks
S
 

yodon

Staff member
Super Moderator
#4
That subject is probably too broad for a discussion board. You need to review the regulations and understand relevant guidance docs / standards to really drill down on content requirements. For example, if your product has software then you will have software requirements (as part of the design inputs). IEC 62304 lists out types of requirements that would be expected. The software requirements also need to trace to system requirements (another design input). 62304 also has a software risk aspect (if class B or C) and those may also drive software requirements. ISO 14971 (risk management) and IEC 62366 (Usability Engineering) would potentially drive other software requirements and the linkage between the source of the software requirements and the origination should be maintained. So as you can see, things get rather complicated rather quickly.
 
Thread starter Similar threads Forum Replies Date
Watchcat ISO 13485 for IVD (In-vitro Diagnostic Device) Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 10
M Informational TGA – European implementation of Medical Device and IVD Regulations – Implications for Australia Medical Device and FDA Regulations and Standards News 0
P Usability/human factors engineering requirement (standard) for IVD medical device Other Medical Device Related Standards 2
R Medical Device (IVD) - Selling RUO to Customers EU Medical Device Regulations 2
I Another design change or new product? IVD device ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO 13485 Medical Device File requirements for IVD ISO 13485:2016 - Medical Device Quality Management Systems 1
T Is an EEG (Electroencephalogram) an IVD or a Medical Device? Other US Medical Device Regulations 14
D Help needed for Compliance Road-Map - Startup making their first device (IVD) IEC 62304 - Medical Device Software Life Cycle Processes 1
F IVD/Medical Device Registration (with MHRA DORS account in the UK) EU Medical Device Regulations 3
F CE and FDA Mark on same IVD/Medical Device Label EU Medical Device Regulations 12
N New MDR EU Medical Device/IVD Regulations - Definition of Importer EU Medical Device Regulations 1
P Content of an IVD Technical Dossier to Register a Device to Japan Japan Medical Device Regulations 0
H UDI (Unique Device Identification) Requirements for IVD Software EU Medical Device Regulations 2
P IVD device distribution, what to do? Japan Medical Device Regulations 1
F CE Marking Algorithm for an IVD use only Medical Device EU Medical Device Regulations 7
Ajit Basrur New Medical Device and IVD Registration Rules - Pakistan Other Medical Device Regulations World-Wide 5
E Republic Of Georgia Medical Device Regulations for IVD Other Medical Device Regulations World-Wide 6
R Shipping Stability for Class III IVD (Non Sterile) Medical Device Other Medical Device Related Standards 7
J FDA Compliant Quality System for Virtual Manufacturing (IVD Medical Device)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
W IVD Medical Device Registration in Indonesia Other Medical Device Regulations World-Wide 2
E IVD Medical Device Product Registration in Myanmar Other Medical Device Regulations World-Wide 3
E IVD Medical Device Product Registration in Indonesia Other Medical Device Regulations World-Wide 2
K South Korea IVD Medical Device Classifications Other Medical Device Regulations World-Wide 13
P IVD Medical Device Authorized Representative Requirements in EU EU Medical Device Regulations 6
bio_subbu GHTF issues revised document "Definitions of ?Medical Device? and ?IVD? Other Medical Device Regulations World-Wide 1
S IVD Device Registration in France by our local AR EU Medical Device Regulations 5
W Insulation Grade for In Vitro Diagnostic (IVD) Device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Medical Device/IVD Manufacturer Supplier Requirements - Compliant to ISO 13485?? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Comparative Study - 510(K) IVD (in vitro diagnostic) Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
G RoHS Changes Coming in 2012? Expansion to include med device, IVD's, analyzers? RoHS, REACH, ELV, IMDS and Restricted Substances 3
G IVD (In Vitro Diagnostic) MDD (Medical Device Directive) Borderline Issues EU Medical Device Regulations 3
L Canadian Medical Device and IVD (In Vitro Diagnostic) Requirements US Food and Drug Administration (FDA) 3
M IEC 62304 Compliance Status - Is it mandatory for IVD device? IEC 62304 - Medical Device Software Life Cycle Processes 7
bio_subbu USFDA issues Final Guidance Document on InVitro Diagnostic Device (IVD) Studies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Single Medical Device Warranty card for both RUO and IVD!! ISO 13485:2016 - Medical Device Quality Management Systems 1
sagai In Vitro Scanner Device (IVD) FDA Classification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
W Requirements for using Open Source Software in Medical Devices - IVD Medical Device IEC 62304 - Medical Device Software Life Cycle Processes 10
M IEC 60601 vs. IEC 61010 - CE Mark for our IVD medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
J Determining the Appropriate Sampling Regime when Assigning Values to an IVD Device Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
M IVD Device - ISO 13485 and Testing for Environmental Operation Specifications ISO 13485:2016 - Medical Device Quality Management Systems 3
J IVD sampling sizes for buyer Reliability Analysis - Predictions, Testing and Standards 0
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
A CE-IVD Technical File with Multiple IFUs EU Medical Device Regulations 4
A Ethics Committee Review Process for IVD Products EU Medical Device Regulations 2
F IVD registration in EU - Northern Ireland based company EU Medical Device Regulations 0
J IVD registration renewal in China China Medical Device Regulations 6
S IVD risk class II devices for Brazil and MDSAP Other Medical Device Regulations World-Wide 0
A IVD in MDR procedure pack EU Medical Device Regulations 2
H Software Interface Translation IVD Regulation EU Medical Device Regulations 0
I IVD - 98/79EC - class IIa - Annex to the EC from the NB states the CM as one of the facilities? CE Marking (Conformité Européene) / CB Scheme 2

Similar threads

Top Bottom