Archived Specifications and Drawings for Medical Device Technical Files

LostLouie

LostLouie

Starting to get Involved
#1
#1
Dear fellow Covers, I've been requested to create a Specification list for our Technical Files. I wondered if the regulations instruct that we need to document past revisions of drawings and specifications in these files (as I can't find where they do)?
Thanks in advance.
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
Y

yodon

Leader
Super Moderator
#2
#2
If you're talking about the Technical File that's reviewed by a Notified Body, that's a snapshot of a particular instance (and updated as things change). Your Document Control and Record Control procedures, though, have to address retention (of obsolete materials). There ARE regulations for those; e.g., see MDR Article 10, item 8.
 
M

monoj mon

Trusted Information Resource
#3
#3
LostLouie said:
I wondered if the regulations instruct that we need to document past revisions of drawings and specifications in these files
Click to expand...
If your past revisions are linked to 'previous generation(s)' then,
MDR 2017/745, Annex II, Section 1.2 (a) 1631064720663.png
MDR 2017/745, Article 32, Section 2 (c)
1631064852680.png
No particular instruction on to include 'drawings and specification', but I guess to describe the differences/similarities you would need one!
 
LostLouie

LostLouie

Starting to get Involved
#4
#4
yodon said:
If you're talking about the Technical File that's reviewed by a Notified Body, that's a snapshot of a particular instance (and updated as things change). Your Document Control and Record Control procedures, though, have to address retention (of obsolete materials). There ARE regulations for those; e.g., see MDR Article 10, item 8.
Click to expand...
Thank you for this reference.
 
LostLouie

LostLouie

Starting to get Involved
#5
#5
monoj mon said:
If your past revisions are linked to 'previous generation(s)' then,
MDR 2017/745, Annex II, Section 1.2 (a) View attachment 28166
MDR 2017/745, Article 32, Section 2 (c)
View attachment 28167
No particular instruction on to include 'drawings and specification', but I guess to describe the differences/similarities you would need one!
Click to expand...
Thanks so much for this confirmation. Can I assume that it is purely an MDR requirement? (ISO 13485:2016 only states "..relevant versions of applicable documents are available ..." )
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Reference to an archived template in multiple SOPs ISO 13485:2016 - Medical Device Quality Management Systems 2
L Does ISO 9001 require that hard copies of documents be archived? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
M Requesting Information From FDA concerning Archived 510K 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
M GHTF (Global Harmonization Task Force) "Archived" Document question EU Medical Device Regulations 3
M Validating 3rd Party Software which Tracks Archived Samples Qualification and Validation (including 21 CFR Part 11) 2
J Common Specifications per MDR EU Medical Device Regulations 2
A Common Specifications versus Harmonized Standards EU Medical Device Regulations 3
C Transfer of Performance specifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
dgrainger Informational DRAFT - Common specifications for the groups of products without an intended medical purpose listed in Annex XVI. EU Medical Device Regulations 0
PQ Systems Defining Quality with Specifications Using SQCpack Software 0
Z E-Coating process International Specifications? FMEA and Control Plans 3
K ASME, ANSI, ASTM and similar specifications and their requirements for document control. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
R EU-MDR Article 9-common specifications Other ISO and International Standards and European Regulations 2
A Oven Controller Specifications - BAC5621 and AMS2750F AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
V Customer Print Specifications on PFMEA FMEA and Control Plans 13
R BS EN 12060:1998 - Zinc and zinc alloys Method of sampling Specifications Manufacturing and Related Processes 4
M MDR "Common Specifications" (CS) - If not standards, then what? EU Medical Device Regulations 6
G Engineering Specifications - APQP APQP and PPAP 5
M Measuring Capability of Process with Multiple Specifications Capability, Accuracy and Stability - Processes, Machines, etc. 6
DuncanGibbons OEM specifications such as AIPS spec from Airbus AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
E Packaging Specifications Mercedes-Benz U.S. International IATF 16949 - Automotive Quality Systems Standard 4
C Taking exception to customer requirements or specifications & AS9100D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
P Software requirement and design specifications - Medical device contains both hardware and software IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational EU – Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited Medical Device and FDA Regulations and Standards News 0
M Specifications Aerospace - Who is responsible for providing the correct specification(s) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
D Raw Material chemical/Tensile Requirements Specifications (QQ-A-250/4, etc) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
2 ASTM or ISO Specifications on Prints Other US Medical Device Regulations 2
R Control of COTS (Commercial Off The Shelf) Specifications ISO 13485:2016 - Medical Device Quality Management Systems 2
I Procedures from recognized standards or specifications ISO 17025 related Discussions 3
S Test Specifications based on Vehicle Type Various Other Specifications, Standards, and related Requirements 0
P Help with 8.5.1 regarding Welding Procedure Specifications (WPS's) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A Technical Documentation - Manufacturing Specifications EU Medical Device Regulations 4
Z How to Contractually Agree on Specifications for Raw Material Purchases Supplier Quality Assurance and other Supplier Issues 15
J Change in Lot Release Specifications - Definition of "Substantial Change" EU Medical Device Regulations 14
T ISO 13485 Label Specifications and Artwork Control ISO 13485:2016 - Medical Device Quality Management Systems 3
alonFAI SMT machine specifications and performance meet the requirements for our production Manufacturing and Related Processes 2
N Subscription Service to Raw Material Specifications AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
W Japanese Steel Specifications - A material called HNCM220M Manufacturing and Related Processes 1
A Procedure for Labeling Review and Approval and Specifications Matrix US Food and Drug Administration (FDA) 2
M Design Inputs - Final Medical Device Specifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Q How to handle customer request for changing specifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
O Functional Specifications - Tracability to requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
H Resistance Temperature Detectors (RTD) Manufacturer's Specifications General Measurement Device and Calibration Topics 3
K Thermocouples Hot Junction and Number of Uses Specifications AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
K What is included in Raw Material and Component Specifications for Medical Devices? Other Medical Device Related Standards 3
A Are Software Requirements Specifications part of Design Input? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T How to keep Customer Engineering Specifications & CSRs Up to Date IATF 16949 - Automotive Quality Systems Standard 6
N Control of Documents Scope - Product Specifications ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
O Specifications as requirements? Other US Medical Device Regulations 8
W Who in your company writes your policies, procedures, specifications etc. Document Control Systems, Procedures, Forms and Templates 10

Similar threads

Top Bottom