Medical Device Website Change Control

C

cmcthorne

#1
Hi all - thanks in advance for your help

I work for a biotech company that aims to be ISO13485 certified by end of 2018.

I am responsible for amongst other things marketing material and the website.

I am curious to hear whether people feel a website's content should fall under controlled documents within an ISO13485 certified company - and if so how this is best managed? For example - if yes, does it have to be the whole webpage, or can specific pages be singled out.

Personally I would like to avoid this, as my experience of website management is that page number can rapidly balloon, often with items that bear no relation to the ISO standard (i.e. investor updates ? ). Further to this - I would be concerned that this would prevent standard A/B page experimentation for page optimisation etc.

I would welcome your thoughts

Thank you again

Chris
 
Elsmar Forum Sponsor
S

suffelde

#2
Write your doc control procedure such that the Website is treated as an informational form, and where needed, as a record (where input is required by user and deemed quality control/assurance related i.e has an impact on cost of good/poor quality).

Where the website has pages which are a function of you QMS, then use your Doc Change Control or you Manage the Change process and treat this situation just like it were a printed controlled document.

That ought to give you some food for thought on how to treat the website.
 

Ronen E

Problem Solver
Moderator
#4
From the regulatory standpoint (ISO 13485 requires compliance with applicable regulatory requirements) some of your website contents might be considered labeling and therefore must be controlled. I wouldn’t think you’d have to control the entire website, but you’d have to have clear guidelines to consistently decide what can be excluded and be able to defend your decisions during audit.

Cheers,
Ronen.
 
Thread starter Similar threads Forum Replies Date
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
Ed Panek Website to ask FDA for guidance in Medical Device Industry? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Ronen E FDA's enforcement over Website Claims (Medical Device Misbranding) Other US Medical Device Regulations 7
C How to find the Medical Device Listing Number (MDL Number) from the FDA website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
L Is there an Official Website for Medical Device Registration Information EU Medical Device Regulations 12
M Medical Device Website Document Control - Clinical Advice or Performance Claims Document Control Systems, Procedures, Forms and Templates 2
V Website Document Control - Medical Device Product Document Control Systems, Procedures, Forms and Templates 10
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
J Medical Device Manufacturing Manufacturing and Related Processes 3
M An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER) EU Medical Device Regulations 0
O Regarding design and development requirements for a medical device EU Medical Device Regulations 6
U Leakage test Standard for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E Tablet integrated into medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
Ed Panek Is this a medical device? US Medical Device Regulations 2
P Medical device testing lab/service standard Other Medical Device Related Standards 1
K Medical Device file and "Component" Manufacturers? Other Medical Device and Orthopedic Related Topics 6
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
C Statistics/sampling plan for medical device Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Non-medical device testing in the medical system IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Training in D&D for engineers with no medical device experience Design and Development of Products and Processes 8
M Software as Medical Device import activities for Chile and Mexico Other Medical Device Regulations World-Wide 0
M Medical Device Indications for Use Health Canada Canada Medical Device Regulations 6
J Average number of Nonconformances during internal quality audit for Medical Device Manufacturers Internal Auditing 3
D Exclusion 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 5
M Lifetime of medical device EU Medical Device Regulations 16
M UDI IVD Medical Device Class III US Food and Drug Administration (FDA) 1
E How to risk assess tooling? For a medical device and is it needed??? Manufacturing and Related Processes 2
P Definition of "Standalone" medical device Other Medical Device Regulations World-Wide 5
B Spare parts of medical device need CE mark? EU Medical Device Regulations 0
R EU MDR Article 22 applicability of medical device with components. EU Medical Device Regulations 4
M Medical Device AE Reporting SOP Medical Device and FDA Regulations and Standards News 0
M Class Exempt Medical Device Recall Question US Food and Drug Administration (FDA) 3
B Technical Documentation for a medical device accessory Medical Device and FDA Regulations and Standards News 6
S Assembling technical file for a medical device ISO 13485:2016 - Medical Device Quality Management Systems 1
K Class I Medical Device Registration EU Medical Device Regulations 11
B Telemedicine as a Medical Device EU Medical Device Regulations 4
S Definition of disease as per medical device defintion EU Medical Device Regulations 14
Q Class I Medical Device with measuring function (UK MDR 2002 / MDD) UK Medical Device Regulations 3
G No new regulations in Austria medical device register after 26th Mai, 2022 EU Medical Device Regulations 0
A What activities are included in the action of marketing you medical device in U.S.? Medical Device and FDA Regulations and Standards News 1
M CE marked medical device - do they need UKAS certified calibration provider ISO 17025 related Discussions 4
C Is there a list of products or classifications subject to medical device regulations in El Salvador? Other Medical Device Regulations World-Wide 0
R Class II Active Medical Device SYSTEMS and COMPONENTS Canada Medical Device Regulations 2
B Rework of a medical device EU regulations EU Medical Device Regulations 5
S Drawing Requirements for Catalog Items (Class II Medical Device) US Food and Drug Administration (FDA) 3
V ADDING NEW MEDICAL DEVICE / Product, WHEATHER THIS AFFECTS EXISTING ISO 13485 CERTIFICATION? ISO 13485:2016 - Medical Device Quality Management Systems 4
C Regulatory Affairs in a start-up medical device company Career and Occupation Discussions 1
somashekar Medical device file Vs Role undertaken by the organization ISO 13485:2016 - Medical Device Quality Management Systems 1
M Medical Device Label - Language EU Medical Device Regulations 2

Similar threads

Top Bottom