Medical Device Website Change Control



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



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
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.

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