Do IFU designs have to be document controlled under ISO 13485?

#1
Hi guys,

I hope someone here can help me. I'm new to QA and medical device field. I'm trying to doc control IFU and was wondering if you need to doc control the design/formatting or just the content? The company I'm working for had the IFU designed on Vista print so I can't download down a modifiable document. Would it be acceptable to doc control a PDF (which the file can be download down as)? The company made custom made medical device hence they are somewhat under TGA radar and is trying to obtain ISO13485 cert.

Any inputs will be much appreciated.
 
Elsmar Forum Sponsor

Jean_B

Trusted Information Resource
#2
Design and formatting can influence comprehension, interpretation, availability and legibility. As such I would expect the formatting to be as controlled (and able to change to respond to risk and opportunity) as its contents.
For a shortlist of reasons consider:
  • the ambiguity that can arise from wrong application of design gestalts (applicable to images as well as text/textblocks, hierarchy is not mentioned but also important),
  • the tendency of (correct) use and process impact (good resource: Writing and Designing Manuals and Warnings [Robinson, Patricia A.] ),
  • and comprehension through the way paragraphs are structured and ordered (which is not content, but design; see also The Sense of Style [Pinker, Steven], which covers that and more).
However, while handy, design control doesn't mean you need to control the editable version. It requires you to control such that you can produce and can verify the produced outputs. As such, your stop-gap of controlling the PDF should be good enough for now.
 
Thread starter Similar threads Forum Replies Date
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 0
J EU 207/2012 E-IFU Service Video EU Medical Device Regulations 1
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
U Intended Users in IFU (Instructions for Use) EU Medical Device Regulations 5
K No IFU, where the requirements would go? EU Medical Device Regulations 5
P IFU Translation Requirements for EU EU Medical Device Regulations 2
V Preparing the IFU in compliance with MDR 745, Chapter III EU Medical Device Regulations 2
E Commission Regulation (EU) No. 207/2012 E-IFU Applicability EU Medical Device Regulations 3
K REF symbol with product code in the IFU EU Medical Device Regulations 1
F Control of medical device IFU content Other Medical Device and Orthopedic Related Topics 3
B Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU? Other Medical Device Related Standards 9
K REF code and Consult IFU in Shipping carton boxes. EU Medical Device Regulations 1
S Providing IFU (Instructions for Use) in multiple languages EU Medical Device Regulations 0
S IFU on web page - Consequences if the most recent one is not uploaded EU Medical Device Regulations 3
I 2017/745 (MDR) - Instruction for use (IFU) - manufacturer's website EU Medical Device Regulations 11
H IFU in different language other than English EU Medical Device Regulations 5
QIE Electronic IFU - new project, need input Other Medical Device and Orthopedic Related Topics 0
Z IFU (Instructions for Use) Symbol - 7010:M002 - can it be in black? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Include IFU in Class II Medical Device Marketing Brochure? US Food and Drug Administration (FDA) 2
M EU Regulations or Standards for instruction for use (IFU ) EU Medical Device Regulations 3
P IVDD - IFU related requirements - Type of information/statement expected EU Medical Device Regulations 1
K Label - IFU requirement, maybe? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Electrosurgical devices/surgery IFU contraindications EU Medical Device Regulations 2
N Updating class I device IFU with instructions to use class II cleared device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Product Instruction for Use Manual (IFU) - Obligation to list the standard used 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Ajit Basrur Incoming Inspection for Instructions for Use (IFU) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Product Instructions (IFU) - Placement Requirements - ISO 13485:2003/2016 Other ISO and International Standards and European Regulations 2
D 207/2012 Update for MDR (?) - Instructions for Use (IFU) EU Medical Device Regulations 9
B IFU and deviation 7 in ISO 14971 Annex ZA ISO 14971 - Medical Device Risk Management 1
F EMC (Electromagnetic Compatibility) Conformity Charts - IFU Requirements Misc. Quality Assurance and Business Systems Related Topics 3
P IFU for Sterling Silver Surgical devices ISO 13485:2016 - Medical Device Quality Management Systems 3
O Regulatory Notification for IVD IFU Instructions Revision ISO 13485:2016 - Medical Device Quality Management Systems 3
E Does posting your IFU on your website constitute elabelling? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
N Is Notified Body approval necessary for small changes to IVD IFU? CE Marking (Conformité Européene) / CB Scheme 7
M Laminating abbreviated Operators Manual to IFU's and DFU's ISO 13485:2016 - Medical Device Quality Management Systems 1
B Brazil ANVISA Medical Device Labeling/IFU Requirements Other Medical Device Regulations World-Wide 1
E IFU Changes - How it is ensured that IFU changes reach Surgeons EU Medical Device Regulations 4
J Canada Bulk Packaging and IFU requirements for Class IIa and IIb Medical Devices Canada Medical Device Regulations 2
J Medical Device Procedure Pack IFU's (Instructions for Use) ISO 13485:2016 - Medical Device Quality Management Systems 5
R How and Where can I find IFU (Instructions For Use) examples? ISO 13485:2016 - Medical Device Quality Management Systems 6
M Orthopedic IFU ( Instruction For Use ) EU Medical Device Regulations 3
J Domestic and International Medical Device IFU (Instructions for Use) Other US Medical Device Regulations 3
G Medical Device IFU (Instructions for Use) Translation Requirements EU Medical Device Regulations 4
E Changes to IFU (Instructions for Use) on a CE Marked Medical Device ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
sagai Electronic Instructions for Use (IFU) of Medical Devices EU Medical Device Regulations 10
R Class II Medical Device - Marketing vs. Indication For Use (IFU) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Providing Instructions for Use (IFU) vs. 'Help' pages 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B Brazil requirements to have translations of IFU to Portuguese certified Other Medical Device Regulations World-Wide 16
C IFU Language Requirements for FDA Clinical Study conducted in EU EU Medical Device Regulations 3
P EU Electronic IFU (Instructions for Use) Requirements EU Medical Device Regulations 2

Similar threads

Top Bottom