Traceability Requirements for Medical Device History Records (DHR's)

E

ElmerF

#1
Hi there,

I'm just looking for a regulation that governs tracebility for medical devices. Specifically my question is: Is it ok to use 2 lots of a component in a sub-assembly Lot History Record. In other words mix componentsbut record both lots numbers. This would mean should you need to trace the materials, you would need to investigate both components. Is this prohibited/ok and if so what is the regulation. I know I have seen this done in Med device LHRs in the past.

thanks,

Elmer
 
Elsmar Forum Sponsor

Michael Malis

Quite Involved in Discussions
#4
Hi there,

I'm just looking for a regulation that governs tracebility for medical devices. Specifically my question is: Is it ok to use 2 lots of a component in a sub-assembly Lot History Record. In other words mix componentsbut record both lots numbers. This would mean should you need to trace the materials, you would need to investigate both components. Is this prohibited/ok and if so what is the regulation. I know I have seen this done in Med device LHRs in the past.

thanks,

Elmer

Elmer,

I would record 2 separate sub-lots. This way, if you need to recall the product, you have the way to segregate materials and recall only 1 sub-lot. However, if the parts are already mixed, it is OK, but you will need to recall it all.

I hope this helps,
Mike
 
Thread starter Similar threads Forum Replies Date
A Active Implantable Medical Devices - Legal Traceability Requirements ISO 13485:2016 - Medical Device Quality Management Systems 7
P Medical Device Raw Material Traceability Requirements Other Medical Device and Orthopedic Related Topics 6
M Medical Device Outsourcing Batch Traceability Requirements Other Medical Device and Orthopedic Related Topics 2
G Medical Device Accessories (e.g.: ECG Patient Cables) - Traceability Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
thisby_ Components Traceability Requirements of a Class I Medical Device US Food and Drug Administration (FDA) 5
F Traceability Requirements for Implantable Medical Devices Other Medical Device Regulations World-Wide 2
P Component Traceability Requirements in a Class 2 Electronic Medical Device Other US Medical Device Regulations 5
J Identification and Traceability in Medical Device Tracking - FDA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S Traceability of requirements to design and risk Design and Development of Products and Processes 3
R Traceability on Unmarked Parts - AS9100 requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
N FDA Traceability Requirements - Component lots ISO 13485:2016 - Medical Device Quality Management Systems 2
N Requirements for the identification and traceability of demo product for sales force US Food and Drug Administration (FDA) 1
A AS5553B Counterfeit Prevention - Traceability requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
T In house Calibration? Measurement equipment traceability requirements - ISO9001 General Measurement Device and Calibration Topics 12
Raffy ISO 13485 NIST Traceability requirements for calibration of test equipment ISO 13485:2016 - Medical Device Quality Management Systems 3
R Drilling Service Identification and Traceability Requirements Quality Manager and Management Related Issues 4
D Are we doing enough to meet Identification and Traceability 7.5.3 Requirements? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
F Traceability Requirements for Computer Hardware Equipment under ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
P What is to be documented to fulfill the requirements of ?820.65 Traceability? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
G Traceability Studies and Requirements for MSA (Measurement Systems Analysis) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
A Design Traceability Matrix Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
Y AS9100C 7.5.3 Identification and Traceability - Interpretation and Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
S ISO 17025 requirements not enough to prove NIST Traceability? ISO 17025 related Discussions 10
J Glue Record and Traceability according FDA Requirements US Food and Drug Administration (FDA) 1
W Requirements Traceability Database - Have one? Help create one? Document Control Systems, Procedures, Forms and Templates 1
I Traceability Requirements TL 9000 Telecommunications Standard and QuEST 5
C Ford Lot Traceability Requirements Customer and Company Specific Requirements 9
J Identification and Traceability requirements - Clause 7.5.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
H What are the requirements of traceability in FDA's Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Traceability of Requirements in the V-Model Qualification and Validation (including 21 CFR Part 11) 3
J Distributor Requirements - Vigilance and Traceability ISO 13485:2016 - Medical Device Quality Management Systems 7
T Class "F" Weight "Certificate of Traceability" Requirements - Calibration General Measurement Device and Calibration Topics 7
S Device History Records (DHR) Component Traceability / Serial Number Requirements ISO 13485:2016 - Medical Device Quality Management Systems 16
B Lot Tracking - Automotive Requirements - Identification and Traceability Records and Data - Quality, Legal and Other Evidence 18
D Traceability Matrix format for tracing user needs - Requirements, specifications, etc Food Safety - ISO 22000, HACCP (21 CFR 120) 11
Y ISO9000-3 - Software Traceability Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Ford and Prototype and Child Parts Traceability - Requirements of Ford Q1 Customer and Company Specific Requirements 4
M Traceability of Raw Materials - Requirements QS-9000 - American Automotive Manufacturers Standard 11
T ISO 9001 8.5.2. - Identification and traceability to Identify Outputs - Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S IATF 16949 - Partial traceability of Aftermarket products IATF 16949 - Automotive Quality Systems Standard 5
R DHR question: Traceability of components ISO 13485:2016 - Medical Device Quality Management Systems 2
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Traceability of component parts - Bolts, screws and washers ISO 13485:2016 - Medical Device Quality Management Systems 3
T Non conformance product identification and traceability 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
B Traceability of Thermoelement Batches ISO 17025 related Discussions 7
G ISO 17025:2017 Uninterrupted chain of traceability for test laboratories ISO 17025 related Discussions 6
J What is the minimum standard for automotive component traceability? Manufacturing and Related Processes 2
A Validation of Calibration Methods and Traceability - ISO 17025 ISO 17025 related Discussions 3
shimonv Design input/output traceability for mechanical parts ISO 13485:2016 - Medical Device Quality Management Systems 13

Similar threads

Top Bottom